OsteoBridge™ Idsf Diaphysis Spacer Connector
OsteoBridge™ Idsf Diaphysis Spacer Connector: 4 catalogue numbers listed by Merete Gmbh, Germany, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product 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 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 20 to 34 mm |
| Distribution end date | 2020-02-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20 | Outer Diameter 20 mm | Withdrawn |
| 25 | Outer Diameter 25 mm | Withdrawn |
| 30 | Outer Diameter 30 mm | Withdrawn |
| 34 | Outer Diameter 34 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.