The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Symmetric Unicompartmental Knee System.
| Device ID | K012800 |
| 510k Number | K012800 |
| Device Name: | SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Contact | Debra Meyer |
| Correspondent | Debra Meyer WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. St. Louis, MO 63141 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-21 |
| Decision Date | 2002-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B046WZ110450 | K012800 | 000 |
| B046WZ110260 | K012800 | 000 |
| B046WZ110250 | K012800 | 000 |
| B046WZ110230 | K012800 | 000 |
| B046WZ110220 | K012800 | 000 |
| B046WZ110210 | K012800 | 000 |
| B046WZ110050 | K012800 | 000 |
| B046WZ110040 | K012800 | 000 |
| B046WZ110030 | K012800 | 000 |
| B046WZ110150 | K012800 | 000 |
| B046WZ110140 | K012800 | 000 |
| B046WZ110020 | K012800 | 000 |
| B046WZ110130 | K012800 | 000 |
| B046WZ110270 | K012800 | 000 |
| B046WZ110290 | K012800 | 000 |
| B046WZ110440 | K012800 | 000 |
| B046WZ110430 | K012800 | 000 |
| B046WZ110420 | K012800 | 000 |
| B046WZ110410 | K012800 | 000 |
| B046WZ110390 | K012800 | 000 |
| B046WZ110380 | K012800 | 000 |
| B046WZ110370 | K012800 | 000 |
| B046WZ110350 | K012800 | 000 |
| B046WZ110340 | K012800 | 000 |
| B046WZ110330 | K012800 | 000 |
| B046WZ110310 | K012800 | 000 |
| B046WZ110300 | K012800 | 000 |
| B046WZ110120 | K012800 | 000 |