In2Bones
Sterile Disposable Instruments for Ø2.4 and Ø 2.7 mm Plate Screws
53manufacturers in China registered for this device type
125catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K170518 |
| Record published | 2024-12-10 |
| 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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P06 S2322 | In distribution | |
| C01 N0002 | In distribution | |
| P02 S0141 | In distribution | |
| P06 N0442 | In distribution | |
| C01 N2101 | In distribution | |
| P06 S0681 | In distribution | |
| P06 N0452 | In distribution | |
| C01 N0061 | In distribution | |
| C01 N0017 | In distribution | |
| P08 N0021 | In distribution | |
| P04 N0031 | In distribution | |
| P07 S0101 | In distribution | |
| P06 S2301 | In distribution | |
| C01 N0071 | In distribution | |
| P04 S0231 | In distribution | |
| C01 N0082 | In distribution | |
| C01 N0001 | In distribution | |
| P07 N0221 | In distribution | |
| P07 N0191 | In distribution | |
| C01 N1022 | In distribution | |
| C01 N0121 | In distribution | |
| C01 N0062 | In distribution | |
| P08 N0041 | In distribution | |
| P08 N0071 | In distribution | |
| P07 N0271 | In distribution | |
| P06 S0001 | In distribution | |
| P06 S2531 | In distribution | |
| P06 N0711 | In distribution | |
| P06 S2291 | In distribution | |
| P07 N0211 | In distribution | |
| C01 S4021 | In distribution | |
| P06 N0771 | In distribution | |
| P07 N0251 | In distribution | |
| C01 N2102 | In distribution | |
| P06 S2331 | In distribution | |
| P06 N0682 | In distribution | |
| C01 S2021 | In distribution | |
| P02 N0141 | In distribution | |
| P04 N0263 | In distribution | |
| C01 N0111 | In distribution | |
| P06 S2332 | In distribution | |
| P04 N0033 | In distribution | |
| P06 N0472 | In distribution | |
| P06 N0621 | In distribution | |
| P06 S2731 | In distribution | |
| P07 N0281 | In distribution | |
| C01 N0009 | In distribution | |
| P06 S2741 | In distribution | |
| P06 N0311 | In distribution | |
| P07 N0201 | In distribution | |
| C01 N2121 | In distribution | |
| P06 N0612 | In distribution | |
| P06 N0651 | In distribution | |
| P07 N0261 | In distribution | |
| P06 S2321 | In distribution | |
| P04 N0023 | In distribution | |
| P04 N0441 | In distribution | |
| C01 N0014 | In distribution | |
| P06 S0711 | In distribution | |
| P04 S0241 | In distribution | |
| C01 S2022 | In distribution | |
| P06 S0461 | In distribution | |
| P08 N0101 | In distribution | |
| P06 N0611 | In distribution | |
| P07 S0131 | In distribution | |
| P08 N0091 | In distribution | |
| P02 N0041 | In distribution | |
| P07 S0141 | In distribution | |
| C01 S1025 | In distribution | |
| P04 N0021 | In distribution | |
| P07 S0271 | In distribution | |
| C01 N0072 | In distribution | |
| P06 S2333 | In distribution | |
| C01 S2019 | In distribution | |
| P04 S0232 | In distribution | |
| P09 S2051 | In distribution | |
| P02 S0161 | In distribution | |
| P06 S2721 | In distribution | |
| P04 S0242 | In distribution | |
| P07 N0121 | In distribution | |
| P04 N0032 | In distribution | |
| P06 S0441 | In distribution | |
| P04 N0034 | In distribution | |
| C01 N0091 | In distribution | |
| P04 N0022 | In distribution | |
| P08 N0051 | In distribution | |
| P08 S0001 | In distribution | |
| C01 N1011 | In distribution | |
| C01 N1012 | In distribution | |
| P08 N0072 | In distribution | |
| C01 S0004 | In distribution | |
| P04 N0024 | In distribution | |
| P06 S0691 | In distribution | |
| C01 N0013 | In distribution | |
| P04 N0041 | In distribution | |
| P04 N0063 | In distribution | |
| C01 N2131 | In distribution | |
| P07 N0181 | In distribution | |
| C01 N0101 | In distribution | |
| P08 N0111 | In distribution | |
| C01 N1031 | In distribution | |
| P09 N0011 | In distribution | |
| P07 N0171 | In distribution | |
| P06 N0491 | In distribution | |
| C01 N0060 | In distribution | |
| P06 S0451 | In distribution | |
| P08 N0011 | In distribution | |
| C01 N1021 | In distribution | |
| C01 N0016 | In distribution | |
| P06 N0462 | In distribution | |
| P06 S0471 | In distribution | |
| C01 N0081 | In distribution | |
| P02 N0161 | In distribution | |
| P06 N0481 | In distribution | |
| P06 S2292 | In distribution | |
| P06 S2341 | In distribution | |
| P04 S0003 | In distribution | |
| C01 N2111 | In distribution | |
| P04 N0091 | In distribution | |
| P07 S0031 | In distribution | |
| C01 N1032 | In distribution | |
| C01 N0010 | In distribution | |
| P04 S0221 | In distribution | |
| P06 S4333 | In distribution | |
| P07 S0111 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2021-08-18 | Class II | Process change control | Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. | 835 units | 2023-08-08 |
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.