Clearance Summary
SURGICAL DRILL BITS received FDA 510(k) clearance under submission number K831712, sponsored by Medical Specialists IN Packaging. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1983-07-07.
- Submission: K831712
- Applicant / Sponsor: Medical Specialists IN Packaging
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1983-07-07
Classification & Regulation
This clearance is catalogued under FDA product code HTW and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.