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FDA 510(k)

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

K-Number: K170571 · 2017-06-20

ApplicantTyber Medical, LLC
Decision Date2017-06-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2017-06-20 under 510(k) number K170571. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw?

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw is a medical device that received FDA 510(k) clearance on 2017-06-20. The listed applicant is Tyber Medical, LLC. The 510(k) number is K170571.

When did Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw receive FDA 510(k) clearance?

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw received FDA 510(k) clearance on 2017-06-20, under 510(k) number K170571.

Who is the listed applicant for Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw?

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

What is the FDA product code for Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw?

The FDA product code for Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw is HWC. This falls under the Cardiovascular category.

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Official Source

View on FDA Database →

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

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