The following data is part of a premarket notification filed by Orthopaedic Biosystems with the FDA for Bioaction Low Profile Screw System.
| Device ID | K922788 |
| 510k Number | K922788 |
| Device Name: | BIOACTION LOW PROFILE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ORTHOPAEDIC BIOSYSTEMS 7725 EAST REDFIELD RD. UNIT 102 Scottsdale, AZ 85260 |
| Contact | Chip Kabrud |
| Correspondent | Chip Kabrud ORTHOPAEDIC BIOSYSTEMS 7725 EAST REDFIELD RD. UNIT 102 Scottsdale, AZ 85260 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1993-03-12 |