510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864423Substantially Equivalent

Raylor(tm) Osteotomes

Cedar Surgical, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864423 is the FDA 510(k) clearance record for RAYLOR(TM) OSTEOTOMES, cleared for Cedar Surgical, Inc. on . FDA records list 17 510(k) clearances for Cedar Surgical, Inc., from to . As of , FDA records show no recalls naming K864423.

Clearance record

Decision date
Received
(14 days to decision)
Review panel
Unknown
Applicant
Cedar Surgical, Inc. 15265 Minnetonka Blvd., Minnetonka MN
Third party review
No