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 |