The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Porous Acetabular System.
| Device ID | K973119 |
| 510k Number | K973119 |
| Device Name: | FOUNDATION POROUS ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Ashley M Bock |
| Correspondent | Ashley M Bock ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-20 |
| Decision Date | 1998-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912085656 | K973119 | 000 |
| 00888912085342 | K973119 | 000 |
| 00888912085335 | K973119 | 000 |
| 00888912085328 | K973119 | 000 |
| 00888912085533 | K973119 | 000 |
| 00888912085526 | K973119 | 000 |
| 00888912085519 | K973119 | 000 |
| 00888912085496 | K973119 | 000 |
| 00888912085489 | K973119 | 000 |
| 00888912085472 | K973119 | 000 |
| 00888912085465 | K973119 | 000 |
| 00888912085366 | K973119 | 000 |
| 00888912085373 | K973119 | 000 |
| 00888912085380 | K973119 | 000 |
| 00888912085649 | K973119 | 000 |
| 00888912085632 | K973119 | 000 |
| 00888912085618 | K973119 | 000 |
| 00888912085601 | K973119 | 000 |
| 00888912085595 | K973119 | 000 |
| 00888912085588 | K973119 | 000 |
| 00888912085571 | K973119 | 000 |
| 00888912084734 | K973119 | 000 |
| 00888912084727 | K973119 | 000 |
| 00888912084710 | K973119 | 000 |
| 00888912085458 | K973119 | 000 |