The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Morphometric Total Hip Prosthesis.
| Device ID | K935185 |
| 510k Number | K935185 |
| Device Name: | MORPHOMETRIC TOTAL HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | LANDOS, INC. 301 LINDENWOOD DR. SUITE ONE Malvern, PA 19355 |
| Contact | Henry P Ferret |
| Correspondent | Henry P Ferret LANDOS, INC. 301 LINDENWOOD DR. SUITE ONE 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 | 1993-10-26 |
| Decision Date | 1994-06-16 |