The following data is part of a premarket notification filed by Whiteside Biomechanics, Inc. with the FDA for Whiteside Biomechanics Cancellous Bone Screw.
| Device ID | K961157 |
| 510k Number | K961157 |
| Device Name: | WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. Creve Coeur, MO 63141 |
| Contact | Michael C Wall, R.n. |
| Correspondent | Michael C Wall, R.n. WHITESIDE BIOMECHANICS, INC. 12634 OLIVE BLVD. Creve Coeur, MO 63141 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-22 |
| Decision Date | 1996-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B046WF110080 | K961157 | 000 |
| B046WF110070 | K961157 | 000 |
| B046WF110060 | K961157 | 000 |
| B046WF110050 | K961157 | 000 |
| B046WF110040 | K961157 | 000 |
| B046WF110030 | K961157 | 000 |
| B046WF110020 | K961157 | 000 |
| B046WF110010 | K961157 | 000 |