Bremer Hifix
BREMER CROWN & RING ACCESSORY SYSTEM W/HIFIX LARGE CROWN 23-26 in. (58-66 cm)
1manufacturer
3catalogue numbers in this listing
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 | Depuy Spine, Inc., United States |
|---|---|
| FDA product code | JEC |
| Device type | Component, Traction, Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K915800 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-31 (version 5) |
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 | 2018-07-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HT036HI | Withdrawn | ||
| HT035HI | Withdrawn | ||
| AC020 | 5 | Withdrawn |
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 |
| Hoffmann | Stryker GmbH | 65 |
| 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 |
Showing 12 of 65. All products under Component, Traction, Invasive
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 715 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 21 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 66 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 6740 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 4843 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 2272 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 1720 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 249 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 157 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 87 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 243 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 86 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 86 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 948 units | 2017-03-27 |
| Depuy Spine, Inc. | 510(k) number | 2006-10-10 | Not classified | Other | Sterility of device is compromised due to loss of package integrity | 635 units | 2017-03-27 |
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.