K854621Substantially Equivalent

Isostation Knee Machine (K-100)

Name: K854621 Isostation Knee Machine (K-100)
Creator: Isotechnologies, Inc.
Published: 1986-03-07
License: https://open.fda.gov/license/

Isotechnologies, Inc., Hillsborough NC / Traditional, Substantially Equivalent

FDA source

K854621 is the FDA 510(k) clearance record for ISOSTATION KNEE MACHINE (K-100), cleared for Isotechnologies, Inc. on 1986-03-07. FDA records list 6 510(k) clearances for Isotechnologies, Inc., from 1984-05-14 to 1994-01-27. As of 2026-09-10, FDA records show no recalls naming K854621.

Clearance record

Decision date: 1986-03-07
Received: 1985-11-18 (109 days to decision)
Review panel: Unknown
Applicant: Isotechnologies, Inc. P.O. Box 1239, Hillsborough NC
Third party review: No