NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE— 510(k) K063374

Substantially Equivalent

Grace Medical, Inc.

FDA 510(k) clearance K063374 for NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE, Substantially Equivalent on 2006-12-06. Applicant: Grace Medical, Inc.. Device class: 2.

Clearance details

Applicant
Grace Medical, Inc.
Product code
Code ETB
Device class
Class 2
Regulation
21 CFR 874.3450
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Memphis, TN, US
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