OsteoBridge™ Interlocking Screw
54 catalogue numbers from 3.8 26, listed by Merete Gmbh, Germany, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
54catalogue numbers in this listing
6510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 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 |
| 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 |
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Merete Gmbh, Germany |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-10-15 |
| Record revised | 2025-06-20 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 18 to 56 mm; outer diameter 3.8 to 5 mm |
| Distribution end date | 2020-02-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.8 26 | In distribution | |
| 3.8 24 | In distribution | |
| 5.0 48 | In distribution | |
| 5.0 52 | In distribution | |
| 3.8 32 | In distribution | |
| 5.0 38 | In distribution | |
| 5.0 50 | In distribution | |
| 5.0 44 | In distribution | |
| 3.8 28 | In distribution | |
| 5.0 24 | In distribution | |
| 5.0 42 | In distribution | |
| 5.0 30 | In distribution | |
| 5.0 46 | In distribution | |
| 5.0 28 | In distribution | |
| 3.8 22 | In distribution | |
| 5.0 56 | In distribution | |
| 3.8 18 | In distribution | |
| 5.0 32 | In distribution | |
| 5.0 54 | In distribution | |
| 3.8 20 | In distribution | |
| 5.0 20 | In distribution | |
| 5.0 22 | In distribution | |
| 5.0 34 | In distribution | |
| 5.0 40 | In distribution | |
| 5.0 36 | In distribution | |
| 5.0 26 | In distribution | |
| 3.8 30 | In distribution | |
| 3.8 32 | Length 32 mm | Withdrawn |
| 3.8 18 | Length 18 mm | Withdrawn |
| 5.0 34 | Length 34 mm | Withdrawn |
| 5.0 20 | Length 20 mm | Withdrawn |
| 5.0 48 | Length 48 mm | Withdrawn |
| 5.0 24 | Length 24 mm | Withdrawn |
| 5.0 22 | Length 22 mm | Withdrawn |
| 3.8 22 | Length 22 mm | Withdrawn |
| 5.0 46 | Length 46 mm | Withdrawn |
| 3.8 20 | Length 20 mm | Withdrawn |
| 5.0 30 | Length 30 mm | Withdrawn |
| 3.8 24 | Length 24 mm | Withdrawn |
| 5.0 50 | Length 50 mm | Withdrawn |
| 5.0 42 | Length 42 mm | Withdrawn |
| 5.0 52 | Length 52 mm | Withdrawn |
| 3.8 30 | Length 30 mm | Withdrawn |
| 5.0 36 | Length 36 mm | Withdrawn |
| 5.0 44 | Length 44 mm | Withdrawn |
| 3.8 26 | Length 26 mm | Withdrawn |
| 5.0 56 | Length 56 mm | Withdrawn |
| 5.0 28 | Length 28 mm | Withdrawn |
| 5.0 38 | Length 38 mm | Withdrawn |
| 5.0 40 | Length 40 mm | Withdrawn |
| 3.8 28 | Length 28 mm | Withdrawn |
| 5.0 32 | Length 32 mm | Withdrawn |
| 5.0 26 | Length 26 mm | Withdrawn |
| 5.0 54 | Length 54 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181026 | 2018-10-17 |
| K142451 | 2015-02-09 |
| K120978 | 2012-05-02 |
| K113303 | 2011-12-09 |
| K101939 | 2010-10-07 |
| K051965 | 2006-06-16 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 2020-09-18 | Class II | Process design | Product may be mislabeled. | 215 units | 2021-05-13 |
| 2020-09-18 | Class II | Process design | Product may be mislabeled. | 354 units | 2021-05-13 |
| 2020-09-18 | Class II | Process design | Product may be mislabeled. | 144 units | 2021-05-13 |
| 2020-09-18 | Class II | Process design | Product may be mislabeled. | 306 units | 2021-05-13 |
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.