The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Hip Joint Metal/polymer Semi-constrained Prothesis.
| Device ID | K921525 |
| 510k Number | K921525 |
| Device Name: | HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | IMPLANT TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son IMPLANT TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium, MD 21093 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-03 |
| Decision Date | 1995-01-11 |