T2, Pangea
Lateral Npcp Inserter, L
22manufacturers in China registered for this device type
46catalogue numbers in this listing
25510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2025-09-25 |
| Record revised | 2026-07-30 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 155 to 438 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6497-4-040S | Thickness: 5.0 Millimeter | In distribution |
| 6497-2-090S | Side: RIGHT | In distribution |
| 6497-1-140S | Length 438.0 mm | In distribution |
| 6497-2-090 | Side: RIGHT | In distribution |
| 6497-1-130 | Side: LEFT | In distribution |
| 6497-2-120S | Length 394.0 mm | In distribution |
| 6497-4-040 | Side: RIGHT | In distribution |
| 6497-2-130S | Length 416.0 mm | In distribution |
| 6497-1-080 | Side: LEFT | In distribution |
| 6497-2-100S | Length 350.0 mm | In distribution |
| 6497-1-130S | Length 416.0 mm | In distribution |
| 543140 | Side: LEFT | In distribution |
| 6497-2-080 | Length 306.0 mm | In distribution |
| 6497-1-080S | Side: LEFT | In distribution |
| 6497-1-100S | Length 350.0 mm | In distribution |
| 6497-1-060 | Side: LEFT | In distribution |
| 6497-2-060S | Thickness: 5.0 Millimeter | In distribution |
| 543170 | Side: RIGHT | In distribution |
| 6497-2-070S | Length 284.0 mm | In distribution |
| 6497-1-090S | Thickness: 5.0 Millimeter | In distribution |
| 6497-2-060 | Side: RIGHT | In distribution |
| 6497-2-110S | Side: RIGHT | In distribution |
| 6497-2-110 | Thickness: 5.0 Millimeter | In distribution |
| 6497-3-040S | Thickness: 5.0 Millimeter | In distribution |
| 6497-1-110S | Length 372.0 mm | In distribution |
| 6497-2-140 | Side: RIGHT | In distribution |
| 6497-1-120 | Thickness: 5.0 Millimeter | In distribution |
| 6497-1-110 | Length 372.0 mm | In distribution |
| 6497-3-100S | Length 265.0 mm | In distribution |
| 6497-2-120 | Thickness: 5.0 Millimeter | In distribution |
| 6497-2-130 | Length 416.0 mm | In distribution |
| 6497-2-070 | Length 284.0 mm | In distribution |
| 6497-2-080S | Length 306.0 mm | In distribution |
| 6497-1-120S | Side: LEFT | In distribution |
| 6497-4-100S | Thickness: 5.0 Millimeter | In distribution |
| 6497-1-070S | Thickness: 5.0 Millimeter | In distribution |
| 6497-1-060S | Length 262.0 mm | In distribution |
| 6497-3-100 | Length 265.0 mm | In distribution |
| 6497-2-140S | Thickness: 5.0 Millimeter | In distribution |
| 6497-3-040 | Side: LEFT | In distribution |
| 6497-1-140 | Length 438.0 mm | In distribution |
| 6497-1-090 | Side: LEFT | In distribution |
| 6497-2-100 | Length 350.0 mm | In distribution |
| 6497-1-070 | Side: LEFT | In distribution |
| 6497-4-100 | Thickness: 5.0 Millimeter | In distribution |
| 6497-1-100 | Side: LEFT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242445 | 2024-10-06 |
| K233919 | 2024-03-25 |
| K231257 | 2023-08-18 |
| K231262 | 2023-08-18 |
| K222381 | 2023-04-27 |
| K223772 | 2023-04-07 |
| K221346 | 2022-07-08 |
| K212581 | 2022-01-19 |
| K200398 | 2020-06-05 |
| K192675 | 2019-11-22 |
| K191412 | 2019-08-23 |
| K183172 | 2019-03-05 |
| K181091 | 2018-10-11 |
| K172148 | 2018-03-19 |
| K172350 | 2017-12-15 |
| K170727 | 2017-06-22 |
| K170771 | 2017-05-08 |
| K162841 | 2017-02-21 |
| K162439 | 2017-02-03 |
| K153379 | 2016-05-26 |
| K151769 | 2015-10-27 |
| K151879 | 2015-08-06 |
| K113109 | 2011-12-23 |
| K112926 | 2011-12-19 |
| K110476 | 2011-03-18 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2019-12-05 | Class II | Under Investigation by firm | Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. | 433 (289 units U.S. / 144 units OUS) | 2020-10-09 |
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.