BERLIN EXTERNAL FIXATOR— 510(k) K954053

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K954053 for BERLIN EXTERNAL FIXATOR, Substantially Equivalent on 1996-05-16. Applicant: Encore Orthopedics, Inc..

Clearance details

Applicant
Encore Orthopedics, Inc.
Product code
Code LXT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
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