The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Porous Coated Hemispherical Shell.
| Device ID | K974093 |
| 510k Number | K974093 |
| Device Name: | FOUNDATION POROUS COATED HEMISPHERICAL SHELL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos 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 | 1997-10-30 |
| Decision Date | 1998-01-28 |
| Summary: | summary |