K833461Substantially Equivalent

Hs4 Head/neck Femoral Prostheses

Name: K833461 Hs4 Head/neck Femoral Prostheses
Creator: Osteonics Corp.
Published: 1983-12-27
License: https://open.fda.gov/license/

Osteonics Corp., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K833461 is the FDA 510(k) clearance record for HS4 HEAD/NECK FEMORAL PROSTHESES, cleared for Osteonics Corp. on 1983-12-27. 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 K833461.

Clearance record

Decision date: 1983-12-27
Received: 1983-10-05 (83 days to decision)
Review panel: Unknown
Applicant: Osteonics Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No