CoLag™
SCREW, FT, Ø6.7X100.0 mm
22manufacturers in China registered for this device type
64catalogue numbers in this listing
16510(k) clearances naming this product code
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 | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 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 ST647 | In distribution | |
| P65 ST547 | In distribution | |
| P65 ST557 | In distribution | |
| P65 ST890 | In distribution | |
| P65 ST542 | In distribution | |
| P65 ST885 | In distribution | |
| P65 ST900 | In distribution | |
| P65 ST530 | In distribution | |
| P65 ST677 | In distribution | |
| P65 ST687 | In distribution | |
| P65 ST657 | In distribution | |
| P65 ST040 | In distribution | |
| P65 ST910 | In distribution | |
| P65 ST567 | In distribution | |
| P65 ST870 | In distribution | |
| P65 ST630 | In distribution | |
| P65 ST634 | In distribution | |
| P65 ST695 | In distribution | |
| P65 ST836 | In distribution | |
| P65 ST875 | In distribution | |
| P65 ST562 | In distribution | |
| P65 ST534 | In distribution | |
| P65 ST715 | In distribution | |
| P65 ST845 | In distribution | |
| P65 ST652 | In distribution | |
| P65 ST067 | In distribution | |
| P65 ST667 | In distribution | |
| P65 ST662 | In distribution | |
| P65 ST642 | In distribution | |
| P65 ST855 | In distribution | |
| P65 ST850 | In distribution | |
| P65 ST672 | In distribution | |
| P65 ST552 | In distribution | |
| P65 ST638 | In distribution | |
| P65 ST682 | In distribution | |
| P65 ST705 | In distribution | |
| P65 ST538 | In distribution | |
| P65 ST832 | In distribution | |
| P65 ST840 | In distribution | |
| P65 ST880 | In distribution | |
| P65 ST860 | In distribution | |
| P65 ST865 | In distribution | |
| P65 ST328 | Withdrawn | |
| P65 ST212 | Withdrawn | |
| P65 ST442 | Withdrawn | |
| P65 ST228 | Withdrawn | |
| P65 ST332 | Withdrawn | |
| P65 ST224 | Withdrawn | |
| P65 ST320 | Withdrawn | |
| P65 ST452 | Withdrawn | |
| P65 ST340 | Withdrawn | |
| P65 ST438 | Withdrawn | |
| P65 ST447 | Withdrawn | |
| P65 ST434 | Withdrawn | |
| P65 ST216 | Withdrawn | |
| P65 ST324 | Withdrawn | |
| P65 ST316 | Withdrawn | |
| P65 ST457 | Withdrawn | |
| P65 ST312 | Withdrawn | |
| P65 ST430 | Withdrawn | |
| P65 ST336 | Withdrawn | |
| P65 ST426 | Withdrawn | |
| P65 ST422 | Withdrawn | |
| P65 ST220 | Withdrawn |
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 |
|---|---|
| K241387 | 2024-08-13 |
| K233089 | 2024-05-24 |
| K213698 | 2022-05-27 |
| K213069 | 2021-12-13 |
| K212487 | 2021-11-18 |
| K210060 | 2021-03-12 |
| K201149 | 2020-07-15 |
| K200762 | 2020-04-23 |
| K193543 | 2020-01-17 |
| K190385 | 2019-08-08 |
| K191535 | 2019-07-29 |
| K182402 | 2018-09-27 |
| K181113 | 2018-06-15 |
| K172300 | 2017-11-27 |
| K170518 | 2017-07-14 |
| K163293 | 2017-05-05 |
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.