The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Whiteside Biomechanics Zirconia Ceramic Femoral Head.
| Device ID | K964150 |
| 510k Number | K964150 |
| Device Name: | WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC 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 | 1996-10-16 |
| Decision Date | 1996-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B046WD110200 | K964150 | 000 |
| B046WD110180 | K964150 | 000 |