K862945Substantially Equivalent

Downs Surgical Titanium Autocompression Plates

Name: K862945 Downs Surgical Titanium Autocompression Plates
Creator: Downs Surgical , Ltd.
Published: 1986-08-20
License: https://open.fda.gov/license/

Downs Surgical, Ltd., Wilmington MA / Traditional, Substantially Equivalent

FDA source

K862945 is the FDA 510(k) clearance record for DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES, cleared for Downs Surgical , Ltd. on 1986-08-20. FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from 1980-01-21 to 1990-10-31. As of 2026-09-10, FDA records show no recalls naming K862945.

Clearance record

Decision date: 1986-08-20
Received: 1986-08-05 (15 days to decision)
Review panel: Unknown
Applicant: Downs Surgical , Ltd. 42 Industrial Way, Wilmington MA
Third party review: No