Appliance, Fixation, Spinal Interlaminal
Instrument 8161214 2PRNG 14MM S Stpl TRL
11manufacturers in China registered for this device type
41catalogue numbers in this listing
44510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K113174 |
| Record published | 2019-03-08 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 15 to 110 mm; outer diameter 4 to 10.5 mm |
| Distribution end date | 2025-12-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0312665 | Length 95.0 mm | In distribution |
| X0312531 | Length 20.0 mm | In distribution |
| X0312589 | Length 55.0 mm | In distribution |
| X0312575 | Length 80.0 mm | In distribution |
| X0312591 | Length 65.0 mm | In distribution |
| X0312537 | Length 20.0 mm | In distribution |
| 5584119 | In distribution | |
| X0312610 | Outer Diameter 8.5 mm | In distribution |
| 9240215 | In distribution | |
| X0312493 | Outer Diameter 4.0 mm | In distribution |
| X0312569 | Outer Diameter 7.5 mm | In distribution |
| 7376005 | In distribution | |
| X0312538 | Outer Diameter 6.0 mm | In distribution |
| X0312622 | Length 65.0 mm | In distribution |
| X0312580 | Length 110.0 mm | In distribution |
| X0312648 | Length 40.0 mm | In distribution |
| X0312659 | Length 95.0 mm | In distribution |
| X0312550 | Length 15.0 mm | In distribution |
| X0312598 | Outer Diameter 8.0 mm | In distribution |
| X0312590 | Outer Diameter 8.0 mm | In distribution |
| X0312523 | Length 25.0 mm | In distribution |
| X0312656 | Length 80.0 mm | In distribution |
| X0312542 | Length 45.0 mm | In distribution |
| X0312562 | Length 50.0 mm | In distribution |
| X0312597 | Outer Diameter 8.0 mm | In distribution |
| X0312519 | Length 45.0 mm | In distribution |
| X0312585 | Outer Diameter 8.0 mm | In distribution |
| X0312632 | Length 30.0 mm | In distribution |
| X0312608 | Length 80.0 mm | In distribution |
| X0312516 | Length 60.0 mm | In distribution |
| X0312633 | Length 35.0 mm | In distribution |
| 1850096 | In distribution | |
| X0312555 | Length 15.0 mm | In distribution |
| X0312540 | Length 35.0 mm | In distribution |
| 7372572 | Length 72.5 mm | Withdrawn |
| 8161214 | 14mm | Withdrawn |
| 8161212 | 12mm | Withdrawn |
| X0312666 | Outer Diameter 10.5 mm | Withdrawn |
| X0312517 | Length 55.0 mm | Withdrawn |
| 8161208 | 8mm | Withdrawn |
| 8161410 | 10mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121191 | 2012-06-29 |
| K102886 | 2011-01-26 |
| K090714 | 2009-04-17 |
| K083071 | 2008-11-14 |
| K081297 | 2008-06-11 |
| K080805 | 2008-04-18 |
| K071942 | 2007-12-11 |
| K062447 | 2007-10-15 |
| K070742 | 2007-09-14 |
| K061591 | 2006-09-08 |
| K061579 | 2006-08-11 |
| K060081 | 2006-02-13 |
| K052734 | 2005-10-21 |
| K052376 | 2005-09-23 |
| K052402 | 2005-09-23 |
| K052180 | 2005-08-23 |
| K050484 | 2005-05-04 |
| K043053 | 2005-04-11 |
| K043020 | 2005-01-07 |
| K042789 | 2004-12-21 |
| K042524 | 2004-10-08 |
| K042498 | 2004-10-07 |
| K042402 | 2004-10-01 |
| K041862 | 2004-09-15 |
| K041282 | 2004-06-10 |
| K030875 | 2003-06-24 |
| K031533 | 2003-06-13 |
| K030816 | 2003-06-06 |
| K023415 | 2002-12-13 |
| K023797 | 2002-12-13 |
| K014296 | 2002-12-10 |
| K023555 | 2002-11-22 |
| K022191 | 2002-08-28 |
| K021061 | 2002-07-25 |
| K022070 | 2002-07-22 |
| K022015 | 2002-07-18 |
| K020709 | 2002-05-09 |
| K020426 | 2002-02-26 |
| K020155 | 2002-02-05 |
| K014267 | 2002-01-25 |
| K003780 | 2001-09-28 |
| K011508 | 2001-06-12 |
| K010181 | 2001-06-12 |
| K001532 | 2000-06-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2018-07-09 | Class II | Employee error | This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm di | 47 units | 2021-05-07 |
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.