Journey
Journey II Articular Stabilized Xlpe Articular Insert Size 3-4 Right 18MM
21manufacturers in China registered for this device type
1,339catalogue numbers in this listing
49510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111711 |
| Record published | 2015-09-30 |
| Record revised | 2025-10-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: : – |
| Distribution end date | 2022-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 74028217 | In distribution | |
| E0015233-7 | In distribution | |
| 71934500 | In distribution | |
| 74021267 | In distribution | |
| 74025861 | In distribution | |
| 74021163 | Size: 3 left | In distribution |
| 74021156 | In distribution | |
| 74014506 | In distribution | |
| 74031216 | In distribution | |
| E0015374-2 | In distribution | |
| 74028231 | In distribution | |
| 74033545 | In distribution | |
| 74025687 | In distribution | |
| 71934344 | In distribution | |
| 74029257 | In distribution | |
| 74035261 | In distribution | |
| 71934544 | In distribution | |
| 74033661 | In distribution | |
| E0015155-3 | In distribution | |
| 74021347 | In distribution | |
| 74023222 | In distribution | |
| 74029238 | In distribution | |
| 74027261 | In distribution | |
| 74027223 | In distribution | |
| 74021497 | In distribution | |
| 74033522 | In distribution | |
| 74021491 | In distribution | |
| 74025631 | In distribution | |
| 74021337 | In distribution | |
| 74022224 | In distribution | |
| 74023262 | In distribution | |
| 74025646 | In distribution | |
| 74025643 | In distribution | |
| 74025742 | In distribution | |
| 74029284 | In distribution | |
| 74028237 | In distribution | |
| 71934516 | In distribution | |
| 74023221 | In distribution | |
| 74029249 | In distribution | |
| E0015200-8 | In distribution | |
| 74021321 | In distribution | |
| 71934525 | In distribution | |
| 74014509 | In distribution | |
| 71934507 | In distribution | |
| 74035743 | In distribution | |
| 74025855 | In distribution | |
| 71934345 | In distribution | |
| 74035282 | In distribution | |
| 74021327 | In distribution | |
| 74033533 | In distribution | |
| 74014708 | In distribution | |
| 74032130 | In distribution | |
| 74032137 | In distribution | |
| 74034242 | In distribution | |
| 74028276 | In distribution | |
| 74028246 | In distribution | |
| 74025681 | In distribution | |
| 74025722 | In distribution | |
| 74033673 | In distribution | |
| 74025856 | In distribution | |
| 74034244 | In distribution | |
| 74025732 | In distribution | |
| 74031362 | In distribution | |
| 74025812 | In distribution | |
| 74027228 | In distribution | |
| 71933098 | In distribution | |
| 74021452 | In distribution | |
| 74033610 | In distribution | |
| 74021435 | In distribution | |
| 74035764 | In distribution | |
| 74028265 | In distribution | |
| 74028267 | In distribution | |
| V0100033 | In distribution | |
| 74025851 | In distribution | |
| 74028266 | In distribution | |
| 74027226 | In distribution | |
| 74035714 | In distribution | |
| 74025652 | In distribution | |
| 71934524 | In distribution | |
| 71934546 | In distribution | |
| 74033631 | In distribution | |
| 74027263 | In distribution | |
| 74027244 | In distribution | |
| 74034253 | In distribution | |
| 74029285 | In distribution | |
| 74021378 | In distribution | |
| 71934346 | In distribution | |
| 74024216 | In distribution | |
| 74021262 | In distribution | |
| 74025671 | In distribution | |
| 74033502 | In distribution | |
| 74021162 | In distribution | |
| 74021494 | In distribution | |
| 71934350 | In distribution | |
| 74023246 | In distribution | |
| 74035242 | In distribution | |
| E0015278-1 | In distribution | |
| 74018625 | In distribution | |
| 74033513 | In distribution | |
| 74034281 | In distribution | |
| 74023432 | In distribution | |
| 74021358 | In distribution | |
| 74023284 | In distribution | |
| 74024623 | In distribution | |
| 74025838 | In distribution | |
| XK000729-1 | In distribution | |
| 74021375 | In distribution | |
| 74035754 | In distribution | |
| 74014507 | In distribution | |
| 74031228 | In distribution | |
| 74027287 | In distribution | |
| 74021325 | In distribution | |
| 74023116 | In distribution | |
| 74031366 | In distribution | |
| 74025738 | In distribution | |
| 74028258 | In distribution | |
| 74025714 | In distribution | |
| 71932912 | In distribution | |
| 74029278 | In distribution | |
| 74035762 | In distribution | |
| 74032149 | In distribution | |
| 74033684 | In distribution | |
| 74025843 | In distribution | |
| 74035272 | In distribution | |
| 74027235 | In distribution | |
| 74028288 | In distribution | |
| 74025826 | In distribution | |
| 74025746 | In distribution | |
| 74023223 | In distribution | |
| 74028273 | In distribution | |
| 74025647 | In distribution | |
| 74033531 | In distribution | |
| 74029276 | In distribution | |
| 74025773 | In distribution | |
| E0015452-1 | In distribution | |
| 74025772 | In distribution | |
| 74028256 | In distribution | |
| 74025735 | In distribution | |
| 74021256 | In distribution | |
| 74023216 | In distribution | |
| 74021434 | In distribution | |
| 74021345 | In distribution | |
| 74014522 | In distribution | |
| 74022217 | In distribution | |
| 74025854 | In distribution | |
| 74025712 | In distribution | |
| 74025868 | In distribution | |
| 74029253 | In distribution | |
| 74022225 | In distribution | |
| 74023263 | In distribution | |
| 74023215 | In distribution | |
| 74032136 | In distribution | |
| 71934514 | In distribution | |
| 74025845 | In distribution | |
| 74025752 | In distribution | |
| 74033536 | In distribution | |
| E0015554-1 | In distribution | |
| 74024835 | In distribution | |
| E0015529-1 | In distribution | |
| 74021472 | In distribution | |
| 74028263 | In distribution | |
| 74021481 | In distribution | |
| 74032132 | In distribution | |
| 74025636 | In distribution | |
| 74022211 | In distribution | |
| 74029266 | In distribution | |
| E0015170-1 | In distribution | |
| 71933634 | In distribution | |
| 74021422 | In distribution | |
| 71934504 | In distribution | |
| 74035784 | In distribution | |
| 74025823 | In distribution | |
| 74028287 | In distribution | |
| 74021355 | In distribution | |
| 74029248 | In distribution | |
| 74025718 | In distribution | |
| 74035262 | In distribution | |
| 74035243 | In distribution | |
| 74021165 | In distribution | |
| E0016791-1 | In distribution | |
| 74033651 | In distribution | |
| 74027273 | In distribution | |
| E0015526-1 | In distribution | |
| 74024841 | In distribution | |
| E0015294-1 | In distribution | |
| 74033551 | In distribution | |
| 74021446 | In distribution | |
| E0016791-10 | In distribution | |
| 74021423 | In distribution | |
| 74025725 | In distribution | |
| 74025883 | In distribution | |
| 74021486 | In distribution | |
| 74033682 | In distribution | |
| E0015477-1 | In distribution | |
| 74031365 | In distribution | |
| 74025711 | In distribution | |
| 74035224 | In distribution | |
| 74034263 | In distribution | |
| 74033671 | In distribution | |
| 74033567 | In distribution | |
| 74023415 | In distribution | |
| 74021426 | In distribution | |
| E0015233-6 | In distribution | |
| 74035741 | In distribution | |
| 74014707 | In distribution | |
| 74021348 | In distribution | |
| 74022218 | In distribution | |
| 74025822 | In distribution | |
| 71934351 | In distribution | |
| 74022116 | In distribution | |
| 74031160 | In distribution | |
| E0015413-1 | In distribution | |
| 74027252 | In distribution | |
| 74025762 | LEFT SIZE 5-6 10MM: 5-6 left | In distribution |
| 74021484 | In distribution | |
| 74021324 | In distribution | |
| E0015374-6 | In distribution | |
| 74021445 | In distribution | |
| 74025831 | In distribution | |
| 74033509 | In distribution | |
| 74025858 | In distribution | |
| 74022221 | In distribution | |
| 71934352 | In distribution | |
| 74032141 | In distribution | |
| E0015366-2 | In distribution | |
| E0015374-3 | In distribution | |
| 74023218 | In distribution | |
| 74023224 | In distribution | |
| 74014503 | In distribution | |
| 74012456 | In distribution | |
| 74035752 | In distribution | |
| 74025813 | In distribution | |
| 74029219 | In distribution | |
| E0015278-9 | In distribution | |
| 74031368 | In distribution | |
| 74027254 | In distribution | |
| 74027275 | In distribution | |
| 74023435 | In distribution | |
| 74023247 | In distribution | |
| E0015366-4 | In distribution | |
| 74031583 | In distribution | |
| 74022223 | In distribution | |
| E0016791-8 | In distribution | |
| 74021332 | In distribution | |
| 74028247 | In distribution | |
| 74021334 | In distribution | |
| 74035281 | In distribution | |
| 74021482 | In distribution | |
| 74035733 | In distribution | |
| 74021457 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
| Truliant® | Exactech, Inc. | 934 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250677 | 2025-04-02 |
| K230653 | 2023-05-04 |
| K230555 | 2023-03-30 |
| K221939 | 2022-07-26 |
| K220896 | 2022-04-26 |
| K211671 | 2021-08-17 |
| K200227 | 2020-06-04 |
| K200826 | 2020-04-24 |
| K200407 | 2020-03-13 |
| K183010 | 2018-11-28 |
| K180334 | 2018-03-05 |
| K172336 | 2018-01-10 |
| K173331 | 2017-11-16 |
| K170282 | 2017-05-22 |
| K170648 | 2017-05-11 |
| K162775 | 2017-01-13 |
| K150241 | 2015-10-27 |
| K152726 | 2015-10-21 |
| K143226 | 2015-02-12 |
| K142807 | 2014-12-22 |
| K141471 | 2014-11-14 |
| K141585 | 2014-08-21 |
| K140555 | 2014-05-29 |
| K130708 | 2013-12-11 |
| K123159 | 2013-05-03 |
| K121443 | 2012-08-13 |
| K120698 | 2012-05-18 |
| K113482 | 2012-02-27 |
| K112941 | 2011-12-20 |
| K111711 | 2011-09-16 |
| K110837 | 2011-04-22 |
| K101499 | 2010-08-26 |
| K093746 | 2010-04-14 |
| K091014 | 2009-09-29 |
| K082358 | 2008-11-25 |
| K072531 | 2007-12-06 |
| K072858 | 2007-11-20 |
| K071071 | 2007-09-19 |
| K060742 | 2006-05-03 |
| K051229 | 2005-07-20 |
| K042515 | 2005-03-14 |
| K041825 | 2005-03-11 |
| K043440 | 2005-02-18 |
| K041106 | 2004-07-01 |
| K032295 | 2003-08-21 |
| K030301 | 2003-02-25 |
| K022010 | 2002-08-19 |
| K012778 | 2002-03-15 |
| K002740 | 2000-11-30 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2023-09-27 | Class II | Component change control | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XL | 28 units | |
| Smith & Nephew, Inc. | 510(k) number | 2023-09-27 | Class II | Component change control | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XL | 29 units | |
| Smith & Nephew, Inc. | 510(k) number | 2023-08-31 | Class II | Labeling Change Control | The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label. | 8 units | |
| Smith & Nephew, Inc. | 510(k) number | 2022-04-19 | Class II | Nonconforming Material/Component | It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT. | 16 units | 2024-08-16 |
| Smith & Nephew, Inc. | 510(k) number | 2018-06-13 | Class II | Other | The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a r | 10,792 units | |
| Smith & Nephew, Inc. | 510(k) number | 2018-06-13 | Class II | Other | The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a r | 42,050 units | |
| Smith & Nephew, Inc. | 510(k) number | 2018-06-13 | Class II | Other | The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a r | 64642 |
Recalls
33 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-10-02 | Class II | Packaging change control | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label. | 5 units | |
| 2024-10-02 | Class II | Packaging change control | Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label. | 8 units | |
| 2024-10-02 | Class II | Packaging change control | Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label. | 2 units | |
| 2024-10-02 | Class II | Packaging change control | Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label. | 3 units | |
| 2022-06-27 | Class II | Process control | The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks. | 31 devices | 2026-03-25 |
| 2021-05-19 | Class II | Nonconforming Material/Component | The device components experienced a manufacturing process error that resulted in surface damage from product handling. | 5 units | 2023-04-14 |
| 2020-09-21 | Class II | Nonconforming Material/Component | The anterior locking detail does not meet its design specifications. | 47 devices | 2026-05-22 |
| 2020-07-16 | Class II | Nonconforming Material/Component | Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. | 1,845 units | |
| 2019-12-19 | Class II | Process control | LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part | 29 units | 2024-09-04 |
| 2018-12-10 | Class II | Device Design | Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 46 units | 2020-11-03 |
| 2018-12-10 | Class II | Device Design | Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 65 units | 2020-11-03 |
| 2018-12-10 | Class II | Device Design | Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 65 units | 2020-11-03 |
| 2018-12-10 | Class II | Device Design | Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch | 65 units | 2020-11-03 |
| 2018-03-30 | Class II | Packaging process control | The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. | 2019-08-21 | |
| 2018-03-30 | Class II | Packaging process control | The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. | 47 units | 2019-08-21 |
| 2018-03-30 | Class II | Packaging process control | The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. | 72 units | 2019-08-21 |
| 2018-03-30 | Class II | Packaging process control | The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. | 16 units | 2019-08-21 |
| 2018-01-15 | Class II | Process control | The affected products were inadvertently packaged with an incorrect screw component. | 12 units | |
| 2017-09-14 | Class II | Mixed-up of materials/components | The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw. | 10 units | 2020-08-21 |
| 2017-08-01 | Class II | Employee error | Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left. | 27 units | 2019-02-19 |
| 2017-05-30 | Class II | Process control | The incorrect Loctite adhesive was used to assemble the impactor heads. | 36 units | 2021-12-10 |
| 2017-05-30 | Class II | Process control | The incorrect Loctite adhesive was used to assemble the impactor heads. | 46 units | 2021-12-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 22 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 33 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 15 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 6 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 6 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 34 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 33 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 2 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 1 unit | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 24 units | 2017-04-10 |
| 2016-03-11 | Class II | Process control | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | 1 unit | 2017-04-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.