The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Depuy Reclaim Monobloc Revision Femoral Stem.
| Device ID | K221462 |
| 510k Number | K221462 |
| Device Name: | DePuy Reclaim Monobloc Revision Femoral Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DePuy Ireland UC Loughbeg, IE P43 ED82 |
| Contact | Jennifer Hill |
| Correspondent | Jennifer Hill DePuy Ireland UC Loughbeg, IE P43 ED82 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-19 |
| Decision Date | 2022-10-21 |