K834093Substantially Equivalent

Perforator Bur

Name: K834093 Perforator Bur
Creator: Treace Medical, Inc.
Published: 1984-05-02
License: https://open.fda.gov/license/

Treace Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K834093 is the FDA 510(k) clearance record for PERFORATOR BUR, cleared for Treace Medical, Inc. on 1984-05-02. FDA records list 80 510(k) clearances for Treace Medical, Inc., from 1982-09-02 to 1989-01-13. As of 2026-09-10, FDA records show no recalls naming K834093.

Clearance record

Decision date: 1984-05-02
Received: 1983-11-28 (156 days to decision)
Review panel: Unknown
Applicant: Treace Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No