The following data is part of a premarket notification filed by Biomet Uk Ltd. with the FDA for Biolox Delta Ceramic Heads, Biolox Delta Option Ceramic Heads.
| Device ID | K192683 |
| 510k Number | K192683 |
| Device Name: | Biolox Delta Ceramic Heads, Biolox Delta Option Ceramic Heads |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Biomet UK Ltd. Waterton Industrial Estate Bridgend, GB Cf31 3xa |
| Contact | Lisa Ingram |
| Correspondent | Lisa Ingram Biomet UK Ltd. Waterton Industrial Estate Bridgend, GB Cf31 3xa |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MAY |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-02-27 |