K850645Substantially Equivalent

Intra-Arc Disposable Arthroplasty Burrs

Name: K850645 Intra-Arc Disposable Arthroplasty Burrs
Creator: Concept, Inc.
Published: 1985-03-06
License: https://open.fda.gov/license/

Concept, Inc., Clearwater FL / Traditional, Substantially Equivalent

FDA source

K850645 is the FDA 510(k) clearance record for INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS, cleared for Concept, Inc. on 1985-03-06. FDA records list 83 510(k) clearances for Concept, Inc., from 1976-12-21 to 1992-05-01. As of 2026-09-10, FDA records show no recalls naming K850645.

Clearance record

Decision date: 1985-03-06
Received: 1985-02-19 (15 days to decision)
Review panel: Unknown
Applicant: Concept, Inc. 12707 u.s. 19 S., Clearwater FL
Third party review: No