The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Fixation Staple Driver/extractor.
| Device ID | K832884 |
| 510k Number | K832884 |
| Device Name: | FIXATION STAPLE DRIVER/EXTRACTOR |
| Classification | Staple, Fixation, Bone |
| Applicant | WARSAW ORTHOPEDIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-26 |
| Decision Date | 1983-10-20 |