The BioBrace Implant— 510(k) K203267

Substantially Equivalent

Biorez, Inc.

FDA 510(k) clearance K203267 for The BioBrace Implant, Substantially Equivalent on 2021-04-30. Applicant: Biorez, Inc..

Clearance details

Applicant: Biorez, Inc.
Product code: Code OWW
Advisory panel: General, Plastic Surgery
Date received: 2020-11-05
Decision date: 2021-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Haven, CT, US

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