The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Non-porous Stem.
| Device ID | K935449 |
| 510k Number | K935449 |
| Device Name: | FOUNDATION NON-POROUS STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1995-03-30 |