The following data is part of a premarket notification filed by Howmedica Osteonics Corp. A.k.a. Stryker Orthopaedics with the FDA for Restoration Anatomic Shell.
| Device ID | K210893 |
| 510k Number | K210893 |
| Device Name: | Restoration Anatomic Shell |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Howmedica Osteonics Corp. A.k.a. Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Alexandra Kirby |
| Correspondent | Alexandra Kirby Howmedica Osteonics Corp. A.k.a. Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-25 |
| Decision Date | 2021-04-22 |