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FDA 510(k)

The BioBrace Implant

K-Number: K203267 · 2021-04-30

ApplicantBiorez, Inc.
Decision Date2021-04-30
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The BioBrace Implant is the device name listed in this FDA 510(k) record. The listed applicant is Biorez, Inc.. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K203267. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The BioBrace Implant?

The BioBrace Implant is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Biorez, Inc.. The 510(k) number is K203267.

When did The BioBrace Implant receive FDA 510(k) clearance?

The BioBrace Implant received FDA 510(k) clearance on 2021-04-30, under 510(k) number K203267.

Who is the listed applicant for The BioBrace Implant?

The FDA 510(k) record lists Biorez, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The BioBrace Implant?

The FDA product code for The BioBrace Implant is OWW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05997381BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff TearsRECRUITINGNCT07708584Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®RECRUITING

Related Devices (Code: OWW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair BiosciencesK250021RotiumNanofiber Solutions, LLCK242187BioBrace®Conmed CorporationK241906BioBrace® Reinforced ImplantConmed CorporationK240817VersaWrapAlafair Biosciences, Inc.K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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