510(k) K101100

CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 by Conmed Linvatec — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2010
Date Received
April 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type