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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G611WD110080 | K961625 | 000 |
| G611WD110190 | K961625 | 000 |
| G611WD110180 | K961625 | 000 |
| G611WD110170 | K961625 | 000 |
| G611WD110160 | K961625 | 000 |
| G611WD110150 | K961625 | 000 |
| G611WD110140 | K961625 | 000 |
| G611WD110130 | K961625 | 000 |
| G611WD110120 | K961625 | 000 |
| G611WD110110 | K961625 | 000 |
| G611WD110100 | K961625 | 000 |
| G611WD110200 | K961625 | 000 |
| G611WD110210 | K961625 | 000 |
| G611WD110070 | K961625 | 000 |
| G611WD110060 | K961625 | 000 |
| G611WD110050 | K961625 | 000 |
| G611WD110040 | K961625 | 000 |
| G611WD110030 | K961625 | 000 |
| G611WD110020 | K961625 | 000 |
| G611WD110010 | K961625 | 000 |
| G611WD110240 | K961625 | 000 |
| G611WD110230 | K961625 | 000 |
| G611WD110220 | K961625 | 000 |
| G611WD110090 | K961625 | 000 |