T TAP HIP System
4 catalogue numbers from 12-165166, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Composite/Metal. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | KMC |
| Device type | Prosthesis, Hip, Semi-Constrained, Composite/Metal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3340 |
| 510(k) | K853259 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-165166 | 28MM INNER Ø B LINER SIZE | In distribution |
| 12-165170 | 28MM INNER Ø C LINER SIZE | In distribution |
| 12-165174 | 28MM INNER Ø E LINER SIZE | In distribution |
| 12-165178 | 28MM INNER Ø F LINER SIZE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biomet® Hip System | Biomet Orthopedics | 5 |
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.