CoLag™
SCREW, FT, Ø6.7X105.0 mm
31manufacturers in China registered for this device type
64catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K170518 |
| Record published | 2017-08-14 |
| Record revised | 2025-08-04 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-12-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P65 ST650 | In distribution | |
| P65 ST640 | In distribution | |
| P65 ST830 | In distribution | |
| P65 ST834 | In distribution | |
| P65 ST882 | In distribution | |
| P65 ST550 | In distribution | |
| P65 ST857 | In distribution | |
| P65 ST560 | In distribution | |
| P65 ST540 | In distribution | |
| P65 ST690 | In distribution | |
| P65 ST872 | In distribution | |
| P65 ST665 | In distribution | |
| P65 ST887 | In distribution | |
| P65 ST710 | In distribution | |
| P65 ST685 | In distribution | |
| P65 ST842 | In distribution | |
| P65 ST838 | In distribution | |
| P65 ST030 | In distribution | |
| P65 ST862 | In distribution | |
| P65 ST632 | In distribution | |
| P65 ST852 | In distribution | |
| P65 ST867 | In distribution | |
| P65 ST680 | In distribution | |
| P65 ST670 | In distribution | |
| P65 ST895 | In distribution | |
| P65 ST877 | In distribution | |
| P65 ST532 | In distribution | |
| P65 ST570 | In distribution | |
| P65 ST645 | In distribution | |
| P65 ST660 | In distribution | |
| P65 ST905 | In distribution | |
| P65 ST555 | In distribution | |
| P65 ST655 | In distribution | |
| P65 ST636 | In distribution | |
| P65 ST700 | In distribution | |
| P65 ST545 | In distribution | |
| P65 ST847 | In distribution | |
| P65 ST536 | In distribution | |
| P65 ST565 | In distribution | |
| P65 ST915 | In distribution | |
| P65 ST050 | In distribution | |
| P65 ST675 | In distribution | |
| P65 ST226 | Withdrawn | |
| P65 ST222 | Withdrawn | |
| P65 ST450 | Withdrawn | |
| P65 ST440 | Withdrawn | |
| P65 ST330 | Withdrawn | |
| P65 ST420 | Withdrawn | |
| P65 ST460 | Withdrawn | |
| P65 ST214 | Withdrawn | |
| P65 ST322 | Withdrawn | |
| P65 ST424 | Withdrawn | |
| P65 ST432 | Withdrawn | |
| P65 ST218 | Withdrawn | |
| P65 ST455 | Withdrawn | |
| P65 ST326 | Withdrawn | |
| P65 ST338 | Withdrawn | |
| P65 ST445 | Withdrawn | |
| P65 ST436 | Withdrawn | |
| P65 ST314 | Withdrawn | |
| P65 ST230 | Withdrawn | |
| P65 ST334 | Withdrawn | |
| P65 ST428 | Withdrawn | |
| P65 ST318 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261154 | 2026-05-30 |
| K231236 | 2023-07-27 |
| K180377 | 2018-06-20 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 48 units | 2019-02-22 |
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 47 units | 2019-02-22 |
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.