The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Cancellous Screw Washer.
| Device ID | K963420 |
| 510k Number | K963420 |
| Device Name: | CANCELLOUS SCREW WASHER |
| Classification | Washer, Bolt Nut |
| 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 | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-30 |
| Decision Date | 1996-11-15 |
| Summary: | summary |