The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Whiteside Biomechanics Titanium Low-profile Cable, Model Bio-1-1013.
| Device ID | K993903 |
| 510k Number | K993903 |
| Device Name: | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-16 |
| Decision Date | 2000-02-14 |
| Summary: | summary |