K862755Substantially Equivalent for Some Indications

Dunn Anterior Distraction System

Name: K862755 Dunn Anterior Distraction System
Creator: Osteotek, Inc.
Published: 1987-01-22
License: https://open.fda.gov/license/

Osteotek, Inc., Salt Lake City UT / Traditional, Substantially Equivalent for Some Indications

FDA source

K862755 is the FDA 510(k) clearance record for DUNN ANTERIOR DISTRACTION SYSTEM, cleared for Osteotek, Inc. on 1987-01-22. FDA records list one 510(k) clearance for Osteotek, Inc. As of 2026-09-10, FDA records show no recalls naming K862755.

Clearance record

Decision date: 1987-01-22
Received: 1986-07-22 (184 days to decision)
Review panel: Unknown
Applicant: Osteotek, Inc. 559 E. S. Temple St., Salt Lake City UT
Third party review: No