Hoffmann
Baltimore Rod To Rod Coupling Compact 5,5mm
1manufacturer
65catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K792561 |
| Record published | 2016-09-24 |
| Record revised | 2026-06-24 (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 |
| Sizes | Length 30 to 500 mm; angle 30 to 90 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5079-5-090 | Diameter: 3.0 Millimeter | In distribution |
| 5029-8-820 | Length 200.0 mm | In distribution |
| 5049-5-100 | Length 100.0 mm | In distribution |
| 5029-8-810 | Length 100.0 mm | In distribution |
| 5049-5-530 | Length 300.0 mm | In distribution |
| 5049-5-300 | Diameter: 5.0 Millimeter | In distribution |
| 5029-8-630 | Diameter: 8.0 Millimeter | In distribution |
| 4940-1-100 | In distribution | |
| 4920-2-020 | Screw Holes: 5.0 Holes | In distribution |
| 5029-7-030 | Diameter: 8.0 Millimeter | In distribution |
| 4920-0-015 | Diameter: 20.0 Millimeter | In distribution |
| 5079-5-050 | Length 50.0 mm | In distribution |
| 4920-2-160 | Angle 90.0 ° | In distribution |
| 5029-8-625 | Diameter: 8.0 Millimeter | In distribution |
| 5029-8-650 | Diameter: 8.0 Millimeter | In distribution |
| 5029-8-850 | Length 500.0 mm | In distribution |
| 4940-1-010 | In distribution | |
| 5079-5-030 | Diameter: 3.0 Millimeter | In distribution |
| 4940-2-120 | In distribution | |
| 5049-5-520 | Length 200.0 mm | In distribution |
| 4920-2-060 | Screw Holes: 10.0 Holes | In distribution |
| 5049-5-505 | Length 65.0 mm | In distribution |
| 4920-2-140 | Angle 30.0 ° | In distribution |
| 5079-5-040 | Length 40.0 mm | In distribution |
| 5029-8-635 | Length 350.0 mm | In distribution |
| 5079-5-060 | Length 60.0 mm | In distribution |
| 4940-2-020 | In distribution | |
| 5029-8-825 | Diameter: 8.0 Millimeter | In distribution |
| 4940-1-020 | In distribution | |
| 5049-5-250 | Diameter: 5.0 Millimeter | In distribution |
| 5029-8-645 | Diameter: 8.0 Millimeter | In distribution |
| 4920-0-000 | Diameter: 20.0 Millimeter | In distribution |
| 4940-1-015 | In distribution | |
| 4920-9-810 | In distribution | |
| 5049-5-510 | Length 100.0 mm | In distribution |
| 5049-5-515 | Length 150.0 mm | In distribution |
| 5049-5-200 | Diameter: 5.0 Millimeter | In distribution |
| 5029-8-835 | Diameter: 8.0 Millimeter | In distribution |
| 5079-5-150 | Diameter: 3.0 Millimeter | In distribution |
| 4940-0-015 | In distribution | |
| 5049-5-525 | Length 250.0 mm | In distribution |
| 5029-7-032 | Length 214.0 mm | In distribution |
| 5029-8-805 | Length 65.0 mm | In distribution |
| 5049-7-020 | Diameter: 5.0 Millimeter | In distribution |
| 5029-8-840 | Length 400.0 mm | In distribution |
| 5029-8-610 | Diameter: 8.0 Millimeter | In distribution |
| 5029-8-830 | Length 300.0 mm | In distribution |
| 5029-8-620 | Length 200.0 mm | In distribution |
| 5029-8-615 | Diameter: 8.0 Millimeter | In distribution |
| 5029-8-845 | Diameter: 8.0 Millimeter | In distribution |
| 5029-8-605 | Length 65.0 mm | In distribution |
| 4940-1-058 | In distribution | |
| 5029-8-815 | Length 150.0 mm | In distribution |
| 4920-1-010 | In distribution | |
| 4920-9-830 | In distribution | |
| 4920-9-010 | In distribution | |
| 4920-2-120 | In distribution | |
| 5049-7-018 | Diameter: 5.0 Millimeter | In distribution |
| 5029-7-028 | Length 134.0 mm | In distribution |
| 5079-5-120 | Diameter: 3.0 Millimeter | In distribution |
| 4920-9-020 | In distribution | |
| 4940-2-140 | Angle 30.0 ° | In distribution |
| 4920-1-030 | In distribution | |
| 4920-1-020 | In distribution | |
| 5029-8-640 | Diameter: 8.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 115 |
| Fragment Fixation System | Orthofix SRL | 77 |
| Anjon Bremer Halo System | Anjon Holdings, LLC | 68 |
| Sheffield Ring Fixator | Orthofix SRL | 68 |
| Hybrid Fixator System | Orthofix SRL | 30 |
| Triax | Stryker GmbH | 26 |
| Bremer | Depuy Spine, Inc. | 11 |
| Additional Accessories FOR THE Orthofix System | Orthofix SRL | 10 |
| Component, Traction, Invasive | Synthes Gmbh | 9 |
| Distraction, Internal | KLS-Martin L.P. | 9 |
| Halo Systems | Ossur Americas | 4 |
| DigiFix | Virak Orthopedics LLC | 3 |
Showing 12 of 65. All products under Component, Traction, Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102885 | 2011-01-14 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker GmbH | UDI-DI | 2019-11-21 | Class II | Under Investigation by firm | Pin To Rod Coupling could not clamp the pin and rod as intended | 2020-11-13 | |
| Howmedica Osteonics Corp | 510(k) number | 2005-08-17 | Not classified | Device Design | Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector. | 105 units | 2008-09-24 |
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.