The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Quatroloc Femoral Component & Head.
| Device ID | K961625 |
| 510k Number | K961625 |
| Device Name: | QUATROLOC FEMORAL COMPONENT & HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-26 |
| Decision Date | 1996-09-10 |
| Summary: | summary |