The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Total Hip Prosthesis- Femoral Components.
| Device ID | K913633 |
| 510k Number | K913633 |
| Device Name: | TOTAL HIP PROSTHESIS- FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Webb |
| Correspondent | Webb INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-15 |
| Decision Date | 1991-11-22 |