The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Whiteside Biomechanics, Inc. Ceramic Unipolar Femoral Head.
| Device ID | K973261 |
| 510k Number | K973261 |
| Device Name: | WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Contact | Michael C Wall |
| Correspondent | Michael C Wall WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1997-11-24 |
| Summary: | summary |