Clearance Summary
PRECISION HARVEST & INLAY INSTRUMENT SET received FDA 510(k) clearance under submission number K851339, sponsored by Concept, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1985-07-02.
- Submission: K851339
- Applicant / Sponsor: Concept, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1985-07-02
Classification & Regulation
This clearance is catalogued under FDA product code HWK and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.