510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K811201Substantially Equivalent

Eftekhar Acetabular Standoff

Zimmer GmbH, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811201 is the FDA 510(k) clearance record for EFTEKHAR ACETABULAR STANDOFF, 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 K811201.

Clearance record

Decision date
Received
(20 days to decision)
Review panel
Unknown
Applicant
Zimmer, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No