Clearance Summary
STAPLE INSERTER-EXTRACTOR FOR ARTHROS received FDA 510(k) clearance under submission number K830456, sponsored by Instrument Makar, 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 1983-03-09.
- Submission: K830456
- Applicant / Sponsor: Instrument Makar, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1983-03-09
Classification & Regulation
This clearance is catalogued under FDA product code HXJ and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.