The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation 9mm Forged Cemented Stem.
| Device ID | K961890 |
| 510k Number | K961890 |
| Device Name: | FOUNDATION 9MM FORGED CEMENTED STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashley M Bock |
| Correspondent | Ashley M Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-15 |
| Decision Date | 1996-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912086219 | K961890 | 000 |
| 00888912086073 | K961890 | 000 |
| 00888912086080 | K961890 | 000 |
| 00888912086097 | K961890 | 000 |
| 00888912086103 | K961890 | 000 |
| 00888912086127 | K961890 | 000 |
| 00888912086134 | K961890 | 000 |
| 00888912086141 | K961890 | 000 |
| 00888912086158 | K961890 | 000 |
| 00888912086165 | K961890 | 000 |
| 00888912086172 | K961890 | 000 |
| 00888912086189 | K961890 | 000 |
| 00888912086202 | K961890 | 000 |
| 00888912086066 | K961890 | 000 |