The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Quatroloc Plasma Sprayed Femoral Component.
| Device ID | K964616 |
| 510k Number | K964616 |
| Device Name: | QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Contact | Michael C Wall, R.n. |
| Correspondent | Michael C Wall, R.n. 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 | 1996-10-24 |
| Decision Date | 1997-08-07 |
| Summary: | summary |