The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Quatro M Femoral Component.
| Device ID | K033313 |
| 510k Number | K033313 |
| Device Name: | QUATRO M FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Contact | Amy Cranmer |
| Correspondent | Amy Cranmer WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Product Code | LWJ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-15 |
| Decision Date | 2004-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B046WK110330 | K033313 | 000 |
| B046WK110140 | K033313 | 000 |
| B046WK110130 | K033313 | 000 |
| B046WK11011 | K033313 | 000 |
| B046WK11010 | K033313 | 000 |
| B046WK110090 | K033313 | 000 |
| B046WK110340 | K033313 | 000 |
| B046WK110180 | K033313 | 000 |
| B046WK110240 | K033313 | 000 |
| B046WK110150 | K033313 | 000 |
| B046WK110160 | K033313 | 000 |
| B046WK110320 | K033313 | 000 |
| B046WK110310 | K033313 | 000 |
| B046WK110230 | K033313 | 000 |
| B046WK110220 | K033313 | 000 |
| B046WK110210 | K033313 | 000 |
| B046WK110200 | K033313 | 000 |
| B046WK110190 | K033313 | 000 |
| B046WK110170 | K033313 | 000 |
| B046WK110120 | K033313 | 000 |