The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Whiteside Biomechanics Spinal System.
| Device ID | K991678 |
| 510k Number | K991678 |
| Device Name: | WHITESIDE BIOMECHANICS SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-17 |
| Decision Date | 1999-08-12 |
| Summary: | summary |