K864372Substantially Equivalent

Osteonics Mc1 Metal-Back Acetabular Cup/pmma Space

Name: K864372 Osteonics Mc1 Metal-Back Acetabular Cup/pmma Space
Creator: Osteonics Corp.
Published: 1986-11-25
License: https://open.fda.gov/license/

Osteonics Corp., Allendale NJ / Traditional, Substantially Equivalent

FDA source

K864372 is the FDA 510(k) clearance record for OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE, cleared for Osteonics Corp. on 1986-11-25. FDA records list 178 510(k) clearances for Osteonics Corp., from 1980-02-11 to 2000-04-06. As of 2026-09-10, FDA records show no recalls naming K864372.

Clearance record

Decision date: 1986-11-25
Received: 1986-11-05 (20 days to decision)
Review panel: Unknown
Applicant: Osteonics Corp. 59 Rte. 17, Allendale NJ
Third party review: No