The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Bipolar Femoral Head.
| Device ID | K981238 |
| 510k Number | K981238 |
| Device Name: | BIPOLAR FEMORAL HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-03 |
| Decision Date | 1998-08-21 |
| Summary: | summary |