K860491Substantially Equivalent

Osteo-Mesh Cranial Fairing

Name: K860491 Osteo-Mesh Cranial Fairing
Creator: Xomed, Inc.
Published: 1986-03-28
License: https://open.fda.gov/license/

Xomed, Inc., Jacksonville FL / Traditional, Substantially Equivalent

FDA source

K860491 is the FDA 510(k) clearance record for OSTEO-MESH CRANIAL FAIRING, cleared for Xomed, Inc. on 1986-03-28. FDA records list 46 510(k) clearances for Xomed, Inc., from 1979-09-19 to 2000-12-11. As of 2026-09-10, FDA records show no recalls naming K860491.

Clearance record

Decision date: 1986-03-28
Received: 1986-02-10 (46 days to decision)
Review panel: Unknown
Applicant: Xomed, Inc. 6743 Southpoint Dr. N., Jacksonville FL
Third party review: No