The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Fracture Stem.
| Device ID | K973809 |
| 510k Number | K973809 |
| Device Name: | FOUNDATION FRACTURE STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1998-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912086059 | K973809 | 000 |
| 00888912085939 | K973809 | 000 |
| 00888912085946 | K973809 | 000 |
| 00888912085953 | K973809 | 000 |
| 00888912085977 | K973809 | 000 |
| 00888912085984 | K973809 | 000 |
| 00888912085991 | K973809 | 000 |
| 00888912086004 | K973809 | 000 |
| 00888912086011 | K973809 | 000 |
| 00888912086028 | K973809 | 000 |
| 00888912086042 | K973809 | 000 |
| 00888912085922 | K973809 | 000 |