The following data is part of a premarket notification filed by Landos, Inc. with the FDA for 22.2/+4mm Co Cr & Zirconia Femoral Head.
| Device ID | K970846 |
| 510k Number | K970846 |
| Device Name: | 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LANDOS, INC. 101 LINDENWOOD DRIVE,SUITE 110 Malvern, PA 19355 |
| Contact | Kath Laffan |
| Correspondent | Kath Laffan LANDOS, INC. 101 LINDENWOOD DRIVE,SUITE 110 Malvern, PA 19355 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-06-05 |
| Summary: | summary |