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FDA 510(k)

VeriFixx™ Small Bone Implant

K-Number: K202777 · 2020-11-17

Decision Date2020-11-17
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VeriFixx™ Small Bone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Armis Biopharma, Inc.. It received FDA 510(k) clearance on 2020-11-17 under 510(k) number K202777. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VeriFixx™ Small Bone Implant?

VeriFixx™ Small Bone Implant is a medical device that received FDA 510(k) clearance on 2020-11-17. The listed applicant is Armis Biopharma, Inc.. The 510(k) number is K202777.

When did VeriFixx™ Small Bone Implant receive FDA 510(k) clearance?

VeriFixx™ Small Bone Implant received FDA 510(k) clearance on 2020-11-17, under 510(k) number K202777.

Who is the listed applicant for VeriFixx™ Small Bone Implant?

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

What is the FDA product code for VeriFixx™ Small Bone Implant?

The FDA product code for VeriFixx™ Small Bone Implant is HTY.

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.

Other records listing Armis Biopharma, Inc. as applicant

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.

Related Devices (Code: HTY)

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.

Official Source

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