The following data is part of a premarket notification filed by Total Joint Othopedics, Inc. with the FDA for Biolox Contoura Ceramic Femoral Head.
| Device ID | K191399 |
| 510k Number | K191399 |
| Device Name: | BIOLOX CONTOURA Ceramic Femoral Head |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Total Joint Othopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Contact | Chris Weaber |
| Correspondent | Chris Weaber Total Joint Othopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 |
| Product Code | LZO |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MBL |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-24 |
| Decision Date | 2019-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814703016905 | K191399 | 000 |
| 00814703016806 | K191399 | 000 |
| 00814703016813 | K191399 | 000 |
| 00814703016837 | K191399 | 000 |
| 00814703016844 | K191399 | 000 |
| 00814703016851 | K191399 | 000 |
| 00814703016868 | K191399 | 000 |
| 00814703016875 | K191399 | 000 |
| 00814703016882 | K191399 | 000 |
| 00814703016899 | K191399 | 000 |
| 00814703016790 | K191399 | 000 |