The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Unipolar Femoral Head With Modular Neck Length Sleeves.
| Device ID | K973614 |
| 510k Number | K973614 |
| Device Name: | FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-23 |
| Decision Date | 1997-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912077071 | K973614 | 000 |
| 00888912076760 | K973614 | 000 |
| 00888912076753 | K973614 | 000 |
| 00888912076722 | K973614 | 000 |
| 00888912076692 | K973614 | 000 |
| 00888912023429 | K973614 | 000 |
| 00888912023412 | K973614 | 000 |
| 00888912077064 | K973614 | 000 |
| 00888912077057 | K973614 | 000 |
| 00888912077040 | K973614 | 000 |
| 00888912077033 | K973614 | 000 |
| 00888912077026 | K973614 | 000 |
| 00888912077019 | K973614 | 000 |
| 00888912077002 | K973614 | 000 |
| 00888912076999 | K973614 | 000 |
| 00888912076982 | K973614 | 000 |
| 00888912076975 | K973614 | 000 |
| 00888912076777 | K973614 | 000 |
| 00888912076784 | K973614 | 000 |
| 00888912076951 | K973614 | 000 |
| 00888912076944 | K973614 | 000 |
| 00888912076937 | K973614 | 000 |
| 00888912076920 | K973614 | 000 |
| 00888912076913 | K973614 | 000 |
| 00888912076906 | K973614 | 000 |
| 00888912076890 | K973614 | 000 |
| 00888912076883 | K973614 | 000 |
| 00888912076876 | K973614 | 000 |
| 00888912076852 | K973614 | 000 |
| 00888912076845 | K973614 | 000 |
| 00888912076838 | K973614 | 000 |
| 00888912076821 | K973614 | 000 |
| 00888912076814 | K973614 | 000 |
| 00888912076807 | K973614 | 000 |
| 00888912076791 | K973614 | 000 |
| 00888912076968 | K973614 | 000 |