CoLink™
CoLink® Low-Pro Cortical Screw, Ø3.0X 42.5mm
31manufacturers in China registered for this device type
203catalogue 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) | K163293 |
| Record published | 2017-06-19 |
| Record revised | 2026-04-17 (version 13) |
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, manufacturing date |
| Distribution end date | 2024-12-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V35 ST322 | Ø3.5 x20mm, Locking | In distribution |
| P92 ST047 | In distribution | |
| P92 ST008 | In distribution | |
| P43 ST160 | In distribution | |
| V30 ST312 | Ø3.0 x12mm, Locking | In distribution |
| P43 ST122 | In distribution | |
| P04 N0011 | In distribution | |
| P04 N0121 | In distribution | |
| V30 ST320 | Ø3.0 x20mm, Locking | In distribution |
| P92 ST130 | In distribution | |
| P43 ST142 | In distribution | |
| P92 ST135 | In distribution | |
| P04 N0122 | In distribution | |
| V35 ST434 | Ø3.5 x34mm, Transverse | In distribution |
| P43 ST110 | In distribution | |
| P04 N0112 | In distribution | |
| V35 ST334 | Ø3.5 x34mm, Locking | In distribution |
| P92 ST014 | In distribution | |
| P43 ST042 | In distribution | |
| P04 N0111 | In distribution | |
| P04 N0105 | In distribution | |
| P92 ST142 | In distribution | |
| P04 N0212 | In distribution | |
| P92 ST110 | In distribution | |
| V30 ST336 | Ø3.0 x36mm, Locking | In distribution |
| V35 ST238 | Ø3.5 x38mm, Non-Locking | In distribution |
| P92 ST015 | In distribution | |
| P92 ST022 | In distribution | |
| P92 ST020 | In distribution | |
| P43 ST136 | In distribution | |
| P92 ST109 | In distribution | |
| P92 ST124 | In distribution | |
| P04 N0132 | In distribution | |
| P43 ST052 | In distribution | |
| P92 ST114 | In distribution | |
| P04 N0104 | In distribution | |
| V35 ST214 | Ø3.5 x14mm, Non-Locking | In distribution |
| P92 ST147 | In distribution | |
| P43 ST155 | In distribution | |
| P04 N0102 | In distribution | |
| P92 ST016 | In distribution | |
| V30 ST340 | Ø3.0 x40mm, Locking | In distribution |
| P43 ST030 | In distribution | |
| P04 N0161 | In distribution | |
| P43 ST134 | In distribution | |
| P43 ST040 | In distribution | |
| P04 N0202 | In distribution | |
| P43 ST152 | In distribution | |
| P92 ST213 | In distribution | |
| P92 ST220 | In distribution | |
| P92 ST237 | In distribution | |
| V35 ST230 | Ø3.5 x30mm, Non-Locking | In distribution |
| P43 ST014 | In distribution | |
| V30 ST316 | Ø3.0 x16mm, Locking | In distribution |
| P43 ST116 | In distribution | |
| P92 ST009 | In distribution | |
| P92 ST128 | In distribution | |
| P43 ST050 | In distribution | |
| P43 ST130 | In distribution | |
| P43 ST132 | In distribution | |
| P43 ST055 | In distribution | |
| P92 ST111 | In distribution | |
| P92 ST226 | In distribution | |
| P92 ST132 | In distribution | |
| P04 N0151 | In distribution | |
| P92 ST037 | In distribution | |
| P43 ST038 | In distribution | |
| P92 ST045 | In distribution | |
| P43 ST147 | In distribution | |
| P92 ST222 | In distribution | |
| P43 ST026 | In distribution | |
| P43 ST045 | In distribution | |
| P04 N0173 | In distribution | |
| V30 ST332 | Ø3.0 x32mm, Locking | In distribution |
| P92 ST232 | In distribution | |
| V35 ST226 | Ø3.5 x26mm, Non-Locking | In distribution |
| P04 N0101 | In distribution | |
| P04 N0152 | In distribution | |
| P92 ST230 | In distribution | |
| V35 ST438 | Ø3.5 x38mm, Transverse | In distribution |
| P92 ST042 | In distribution | |
| P92 ST115 | In distribution | |
| P92 ST218 | In distribution | |
| V35 ST234 | Ø3.5 x34mm, Non-Locking | In distribution |
| V35 ST218 | Ø3.5 x18mm, Non-Locking | In distribution |
| P92 ST209 | In distribution | |
| P92 ST012 | In distribution | |
| P04 N0141 | In distribution | |
| P92 ST032 | In distribution | |
| P92 ST028 | In distribution | |
| P92 ST120 | In distribution | |
| P04 N0172 | In distribution | |
| V30 ST328 | Ø3.0 x28mm, Locking | In distribution |
| V35 ST314 | Ø3.5 x14mm, Locking | In distribution |
| V35 ST338 | Ø3.5 x38mm, Locking | In distribution |
| P92 ST247 | In distribution | |
| P04 N0201 | In distribution | |
| V35 ST422 | Ø3.5 x22mm, Transverse | In distribution |
| P92 ST211 | In distribution | |
| P43 ST018 | In distribution | |
| P43 ST150 | In distribution | |
| P92 ST245 | In distribution | |
| P43 ST057 | In distribution | |
| P43 ST024 | In distribution | |
| P04 N0081 | In distribution | |
| P43 ST020 | In distribution | |
| P92 ST113 | In distribution | |
| P43 ST060 | In distribution | |
| P92 ST118 | In distribution | |
| P04 N0142 | In distribution | |
| P43 ST016 | In distribution | |
| P43 ST157 | In distribution | |
| P43 ST112 | In distribution | |
| P92 ST212 | In distribution | |
| P43 ST010 | In distribution | |
| V35 ST326 | Ø3.5 x26mm, Locking | In distribution |
| P92 ST050 | In distribution | |
| P43 ST114 | In distribution | |
| P92 ST018 | In distribution | |
| P04 N0171 | In distribution | |
| P92 ST011 | In distribution | |
| P43 ST118 | In distribution | |
| P92 ST026 | In distribution | |
| P43 ST032 | In distribution | |
| P43 ST138 | In distribution | |
| P43 ST145 | In distribution | |
| V35 ST330 | Ø3.5 x30mm, Locking | In distribution |
| P92 ST145 | In distribution | |
| P92 ST235 | In distribution | |
| P43 ST028 | In distribution | |
| P92 ST024 | In distribution | |
| P43 ST012 | In distribution | |
| P92 ST126 | In distribution | |
| P04 N0191 | In distribution | |
| P43 ST140 | In distribution | |
| P04 N0012 | In distribution | |
| V35 ST426 | Ø3.5 x26mm, Transverse | In distribution |
| P92 ST040 | In distribution | |
| P43 ST036 | In distribution | |
| P43 ST126 | In distribution | |
| V35 ST310 | Ø3.5 x10mm, Locking | In distribution |
| P92 ST116 | In distribution | |
| P92 ST250 | In distribution | |
| V35 ST210 | Ø3.5 x10mm, Non-Locking | In distribution |
| P43 ST108 | In distribution | |
| P92 ST150 | In distribution | |
| P92 ST035 | In distribution | |
| P43 ST008 | In distribution | |
| P92 ST108 | In distribution | |
| P92 ST228 | In distribution | |
| P92 ST030 | In distribution | |
| P92 ST216 | In distribution | |
| P04 N0131 | In distribution | |
| V35 ST318 | Ø3.5 x18mm, Locking | In distribution |
| P92 ST214 | In distribution | |
| P92 ST140 | In distribution | |
| P04 N0181 | In distribution | |
| V35 ST418 | Ø3.5 x18mm, Transverse | In distribution |
| P04 N0103 | In distribution | |
| P92 ST013 | In distribution | |
| P92 ST224 | In distribution | |
| P92 ST112 | In distribution | |
| V35 ST430 | Ø3.5 x30mm, Transverse | In distribution |
| P04 N0211 | In distribution | |
| P43 ST120 | In distribution | |
| P92 ST137 | In distribution | |
| V35 ST222 | Ø3.5 x22mm, Non-Locking | In distribution |
| P92 ST210 | In distribution | |
| P92 ST122 | In distribution | |
| P92 ST010 | In distribution | |
| P43 ST022 | In distribution | |
| P92 ST215 | In distribution | |
| V30 ST324 | Ø3.0 x24mm, Locking | In distribution |
| V30 ST208 | Ø3.0 x 8mm, Non-Locking | In distribution |
| P43 ST124 | In distribution | |
| V30 ST308 | Ø3.0 x8mm, Locking | In distribution |
| P43 ST047 | In distribution | |
| P43 ST128 | In distribution | |
| P92 ST240 | In distribution | |
| P92 ST242 | In distribution | |
| P43 ST034 | In distribution | |
| V50 ST026 | Withdrawn | |
| V50 ST060 | Withdrawn | |
| V50 ST022 | Withdrawn | |
| V50 ST034 | Withdrawn | |
| V50 ST036 | Withdrawn | |
| V30 ST232 | Ø3.0 x32mm, Non-Locking | Withdrawn |
| V50 ST028 | Withdrawn | |
| V50 ST040 | Withdrawn | |
| V50 ST038 | Withdrawn | |
| P92 ST208 | Withdrawn | |
| V50 ST032 | Withdrawn | |
| V50 ST050 | Withdrawn | |
| V50 ST030 | Withdrawn | |
| V50 ST024 | Withdrawn | |
| V30 ST240 | Ø3.0 x40mm, Non-Locking | Withdrawn |
| V50 ST020 | Withdrawn | |
| V50 ST016 | Withdrawn | |
| V50 ST055 | Withdrawn | |
| V50 ST065 | Withdrawn | |
| V50 ST018 | Withdrawn | |
| V50 ST045 | Withdrawn | |
| V30 ST236 | Ø3.0 x36mm, Non-Locking | 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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| IN2BONES USA, LLC | 510(k) number | 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 |
| IN2BONES USA, LLC | 510(k) number | 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 |
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.