The following data is part of a premarket notification filed by Theken Companies with the FDA for Mg-psz Ceramic Femoral Head.
| Device ID | K220336 |
| 510k Number | K220336 |
| Device Name: | Mg-PSZ Ceramic Femoral Head |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Theken Companies 1800 Triplett Blvd Akron, OH 44306 |
| Contact | Garrett Spurgeon |
| Correspondent | Robert A. Poggie BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'lle-Perrot, CA J7V-7P2 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-09-30 |