Acclaim
Acclaim Linked Poly Humeral Yoke
1manufacturer
1catalogue number
2510(k) clearances naming this product code
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 Orthopaedics, Inc., United States |
|---|---|
| FDA product code | JDC |
| Device type | Prosthesis, Elbow, Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K060696 |
| Record published | 2015-09-24 |
| Record revised | 2023-07-19 (version 6) |
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 | 2023-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1722-85-000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nexel® | Zimmer, Inc. | 78 |
| DJO Surgical | Encore Medical, L.P. | 74 |
| Tema Elbow | Limacorporate | 72 |
| Discovery Elbow System | Biomet Orthopedics | 72 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 58 |
| Latitude™ – Elbow | Tornier Inc. | 38 |
| Prosthesis, Elbow, Constrained, Cemented | Zimmer, Inc. | 37 |
| Latitude™ EV | Tornier Inc. | 36 |
| Comprehensive® SRS | Biomet Orthopedics | 31 |
| Comprehensive® SRS Instrument | Biomet Orthopedics | 30 |
| Solar | Howmedica Osteonics Corp | 27 |
| Zimmer® Nexel® Total Elbow | Zimmer, Inc. | 23 |
Showing 12 of 28. All products under Prosthesis, Elbow, Constrained, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060696 | 2006-04-14 |
| K992656 | 1999-11-05 |
Recalls Naming This Product
2 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 | Closed |
|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-11-08 | Not classified | Other | The ulnar bearing may damage the implant’s polyethylene sleeve such that revision surgery is necessary. | 2006-06-16 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2005-11-08 | Not classified | Other | The ulnar bearing may damage the implant’s polyethylene sleeve such that revision surgery is necessary. | 2006-06-16 |
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.