510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K855148Substantially Equivalent for Some Indications

Tharies Fiber

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent for Some Indications

K855148 is the FDA 510(k) clearance record for THARIES FIBER, cleared for Zimmer, Inc. on . FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K855148.

Clearance record

Decision date
Received
(54 days to decision)
Review panel
Unknown
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
Third party review
No