CoLag 2
Colag 2 Screw, Ø4.0X24.0
31manufacturers in China registered for this device type
101catalogue 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) | K180377 |
| Record published | 2018-08-06 |
| Record revised | 2025-08-04 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P67 ST150 | In distribution | |
| P67 ST212 | In distribution | |
| P67 ST250 | In distribution | |
| P68 ST124 | In distribution | |
| P68 ST132 | In distribution | |
| P67 ST110 | In distribution | |
| P67 ST140 | In distribution | |
| P67 ST242 | In distribution | |
| P67 ST322 | In distribution | |
| P67 ST447 | In distribution | |
| P67 ST135 | In distribution | |
| P67 ST334 | In distribution | |
| P67 ST312 | In distribution | |
| P67 ST247 | In distribution | |
| P67 ST218 | In distribution | |
| P67 ST245 | In distribution | |
| P67 ST222 | In distribution | |
| P68 ST138 | In distribution | |
| P68 ST134 | In distribution | |
| P67 ST216 | In distribution | |
| P67 ST330 | In distribution | |
| P67 ST328 | In distribution | |
| P67 ST228 | In distribution | |
| P68 ST160 | In distribution | |
| P67 ST320 | In distribution | |
| P67 ST115 | In distribution | |
| P68 ST120 | In distribution | |
| P67 ST152 | In distribution | |
| P67 ST314 | In distribution | |
| P67 ST132 | In distribution | |
| P67 ST155 | In distribution | |
| P67 ST332 | In distribution | |
| P68 ST142 | In distribution | |
| P68 ST136 | In distribution | |
| P67 ST340 | In distribution | |
| P67 ST116 | In distribution | |
| P67 ST137 | In distribution | |
| P67 ST240 | In distribution | |
| P67 ST338 | In distribution | |
| P67 ST109 | In distribution | |
| P67 ST122 | In distribution | |
| P67 ST237 | In distribution | |
| P67 ST436 | In distribution | |
| P67 ST438 | In distribution | |
| P67 ST445 | In distribution | |
| P67 ST230 | In distribution | |
| P67 ST208 | In distribution | |
| P67 ST124 | In distribution | |
| P67 ST318 | In distribution | |
| P67 ST120 | In distribution | |
| P67 ST130 | In distribution | |
| P67 ST224 | In distribution | |
| P67 ST255 | In distribution | |
| P68 ST147 | In distribution | |
| P67 ST426 | In distribution | |
| P67 ST147 | In distribution | |
| P67 ST420 | In distribution | |
| P67 ST326 | In distribution | |
| P67 ST442 | In distribution | |
| P67 ST112 | In distribution | |
| P67 ST422 | In distribution | |
| P67 ST214 | In distribution | |
| P67 ST108 | In distribution | |
| P67 ST424 | In distribution | |
| P67 ST455 | In distribution | |
| P67 ST128 | In distribution | |
| P67 ST118 | In distribution | |
| P68 ST150 | In distribution | |
| P67 ST226 | In distribution | |
| P67 ST440 | In distribution | |
| P67 ST428 | In distribution | |
| P67 ST232 | In distribution | |
| P67 ST460 | In distribution | |
| P67 ST316 | In distribution | |
| P68 ST152 | In distribution | |
| P67 ST126 | In distribution | |
| P67 ST434 | In distribution | |
| P67 ST252 | In distribution | |
| P68 ST145 | In distribution | |
| P67 ST452 | In distribution | |
| P67 ST220 | In distribution | |
| P67 ST114 | In distribution | |
| P67 ST457 | In distribution | |
| P68 ST122 | In distribution | |
| P67 ST450 | In distribution | |
| P67 ST113 | In distribution | |
| P68 ST130 | In distribution | |
| P68 ST155 | In distribution | |
| P67 ST142 | In distribution | |
| P68 ST157 | In distribution | |
| P68 ST128 | In distribution | |
| P67 ST432 | In distribution | |
| P67 ST336 | In distribution | |
| P68 ST126 | In distribution | |
| P67 ST324 | In distribution | |
| P67 ST145 | In distribution | |
| P67 ST430 | In distribution | |
| P67 ST111 | In distribution | |
| P67 ST210 | In distribution | |
| P68 ST140 | In distribution | |
| P67 ST235 | In distribution |
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.