The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Forged Cemented Stem.
| Device ID | K952191 |
| 510k Number | K952191 |
| Device Name: | FORGED CEMENTED 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 | 1995-05-09 |
| Decision Date | 1995-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912076043 | K952191 | 000 |
| 00888912076036 | K952191 | 000 |
| 00888912076029 | K952191 | 000 |
| 00888912076012 | K952191 | 000 |
| 00888912075992 | K952191 | 000 |
| 00888912075978 | K952191 | 000 |
| 00888912075954 | K952191 | 000 |
| 00888912075930 | K952191 | 000 |