CoLink Afx
Posterolateral Fibula Plate, 4-HOLE, Right, Trial
31manufacturers in China registered for this device type
193catalogue 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) | K181113 |
| Record published | 2018-10-22 |
| Record revised | 2025-08-04 (version 8) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-12-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P07 N1106 | In distribution | |
| P73 ST216 | In distribution | |
| P73 ST030 | In distribution | |
| P72 ST135 | In distribution | |
| P72 ST108 | In distribution | |
| P74 ST018 | In distribution | |
| P73 ST036 | In distribution | |
| P07 N1203 | In distribution | |
| P72 ST120 | In distribution | |
| P07 N1102 | In distribution | |
| P73 ST257 | In distribution | |
| P72 ST230 | In distribution | |
| P74 ST042 | In distribution | |
| P72 ST140 | In distribution | |
| P07 N1401 | In distribution | |
| P07 N1108 | In distribution | |
| P73 ST250 | In distribution | |
| P73 ST057 | In distribution | |
| P72 ST008 | In distribution | |
| P72 ST040 | In distribution | |
| P73 ST212 | In distribution | |
| P73 ST242 | In distribution | |
| P07 N1301 | In distribution | |
| P72 ST118 | In distribution | |
| P72 ST024 | In distribution | |
| P72 ST122 | In distribution | |
| P73 ST112 | In distribution | |
| P74 ST038 | In distribution | |
| P73 ST010 | In distribution | |
| P72 ST228 | In distribution | |
| P72 ST028 | In distribution | |
| P73 ST026 | In distribution | |
| P72 ST045 | In distribution | |
| P73 ST247 | In distribution | |
| P07 N1202 | In distribution | |
| P72 ST012 | In distribution | |
| P73 ST214 | In distribution | |
| P73 ST142 | In distribution | |
| P73 ST145 | In distribution | |
| P07 N1304 | In distribution | |
| P07 N1303 | In distribution | |
| P07 N1105 | In distribution | |
| P74 ST028 | In distribution | |
| P72 ST050 | In distribution | |
| P07 N1402 | In distribution | |
| P73 ST252 | In distribution | |
| P73 ST245 | In distribution | |
| P73 ST224 | In distribution | |
| P07 N1502 | In distribution | |
| P07 N1504 | In distribution | |
| P74 ST047 | In distribution | |
| P72 ST037 | In distribution | |
| P72 ST210 | In distribution | |
| P72 ST224 | In distribution | |
| P73 ST138 | In distribution | |
| P73 ST052 | In distribution | |
| P73 ST260 | In distribution | |
| P73 ST018 | In distribution | |
| P72 ST240 | In distribution | |
| P73 ST124 | In distribution | |
| P07 N1302 | In distribution | |
| P73 ST110 | In distribution | |
| P07 N1113 | In distribution | |
| P72 ST112 | In distribution | |
| P73 ST042 | In distribution | |
| P73 ST236 | In distribution | |
| P73 ST134 | In distribution | |
| P07 N1112 | In distribution | |
| P73 ST122 | In distribution | |
| P72 ST128 | In distribution | |
| P74 ST060 | In distribution | |
| P73 ST157 | In distribution | |
| P72 ST235 | In distribution | |
| P74 ST026 | In distribution | |
| P72 ST216 | In distribution | |
| P72 ST035 | In distribution | |
| P73 ST060 | In distribution | |
| P73 ST128 | In distribution | |
| P07 N1104 | In distribution | |
| P73 ST155 | In distribution | |
| P72 ST010 | In distribution | |
| P72 ST032 | In distribution | |
| P07 N1308 | In distribution | |
| P72 ST218 | In distribution | |
| P73 ST045 | In distribution | |
| P72 ST026 | In distribution | |
| P72 ST116 | In distribution | |
| P74 ST045 | In distribution | |
| P72 ST220 | In distribution | |
| P73 ST120 | In distribution | |
| P74 ST032 | In distribution | |
| P07 N1110 | In distribution | |
| P73 ST016 | In distribution | |
| P74 ST036 | In distribution | |
| P73 ST160 | In distribution | |
| P72 ST018 | In distribution | |
| P74 ST055 | In distribution | |
| P73 ST130 | In distribution | |
| P07 N1206 | In distribution | |
| P07 N1305 | In distribution | |
| P07 N1201 | In distribution | |
| P07 N1204 | In distribution | |
| P73 ST050 | In distribution | |
| P73 ST024 | In distribution | |
| P72 ST232 | In distribution | |
| P73 ST126 | In distribution | |
| P74 ST040 | In distribution | |
| P73 ST022 | In distribution | |
| P73 ST047 | In distribution | |
| P74 ST052 | In distribution | |
| P73 ST116 | In distribution | |
| P72 ST245 | In distribution | |
| P73 ST210 | In distribution | |
| P73 ST132 | In distribution | |
| P07 N1109 | In distribution | |
| P72 ST145 | In distribution | |
| P73 ST136 | In distribution | |
| P74 ST012 | In distribution | |
| P72 ST214 | In distribution | |
| P73 ST032 | In distribution | |
| P07 N1207 | In distribution | |
| P07 N1107 | In distribution | |
| P73 ST020 | In distribution | |
| P73 ST118 | In distribution | |
| P72 ST250 | In distribution | |
| P74 ST016 | In distribution | |
| P73 ST230 | In distribution | |
| P72 ST208 | In distribution | |
| P72 ST150 | In distribution | |
| P72 ST137 | In distribution | |
| P72 ST226 | In distribution | |
| P74 ST050 | In distribution | |
| P74 ST034 | In distribution | |
| P73 ST222 | In distribution | |
| P72 ST126 | In distribution | |
| P74 ST022 | In distribution | |
| P72 ST114 | In distribution | |
| P73 ST147 | In distribution | |
| P73 ST238 | In distribution | |
| P73 ST055 | In distribution | |
| P73 ST255 | In distribution | |
| P73 ST038 | In distribution | |
| P72 ST014 | In distribution | |
| P74 ST024 | In distribution | |
| P73 ST140 | In distribution | |
| P07 N1205 | In distribution | |
| P73 ST034 | In distribution | |
| P73 ST226 | In distribution | |
| P07 N1103 | In distribution | |
| P73 ST014 | In distribution | |
| P72 ST016 | In distribution | |
| P07 N1114 | In distribution | |
| P07 N1310 | In distribution | |
| P74 ST014 | In distribution | |
| P07 N1503 | In distribution | |
| P73 ST218 | In distribution | |
| P72 ST212 | In distribution | |
| P73 ST220 | In distribution | |
| P72 ST110 | In distribution | |
| P73 ST232 | In distribution | |
| P73 ST152 | In distribution | |
| P73 ST028 | In distribution | |
| P73 ST040 | In distribution | |
| P72 ST237 | In distribution | |
| P07 N1011 | In distribution | |
| P73 ST228 | In distribution | |
| P73 ST114 | In distribution | |
| P72 ST124 | In distribution | |
| P73 ST240 | In distribution | |
| P07 N1501 | In distribution | |
| P07 N1309 | In distribution | |
| P72 ST020 | In distribution | |
| P73 ST012 | In distribution | |
| P74 ST010 | In distribution | |
| P07 N1111 | In distribution | |
| P74 ST057 | In distribution | |
| P72 ST030 | In distribution | |
| P72 ST022 | In distribution | |
| P74 ST020 | In distribution | |
| P73 ST150 | In distribution | |
| P72 ST222 | In distribution | |
| P72 ST132 | In distribution | |
| P07 N1307 | In distribution | |
| P07 N1306 | In distribution | |
| P72 ST130 | In distribution | |
| P74 ST030 | In distribution | |
| P73 ST234 | In distribution | |
| P72 ST047 | Withdrawn | |
| P72 ST242 | Withdrawn | |
| P72 ST247 | Withdrawn | |
| P72 ST147 | Withdrawn | |
| P72 ST142 | Withdrawn | |
| P72 ST042 | 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.