The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Compression Screw.
| Device ID | K962779 |
| 510k Number | K962779 |
| Device Name: | COMPRESSION SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Contact | Jeffry B Skiba |
| Correspondent | Jeffry B Skiba ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| 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 | 1996-07-17 |
| Decision Date | 1996-08-23 |
| Summary: | summary |