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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 a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2017-06-20 under approval 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. It is manufactured by Tyber Medical, LLC. The 510(k) number is K170571.

When was Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw approved by the FDA?

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

What company makes Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw?

Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw is manufactured by Tyber Medical, LLC.

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.

Related Clinical Trials

NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07511478 Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle Fractures COMPLETED NCT06636136 Transtibial Osseointegration RECRUITING

Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025)

Other Devices by Tyber Medical, LLC

K161597Tyber Medical BioTy® Nanotopography Trauma Screw K153575Tyber Medical Trauma Screw K172185Tyber Medical PT Interbody Spacer System K171327Tyber Medical Wedge System K180590Tyber Medical PT Interbody Spacer System K182284Tyber Medical PT Interbody Spacer

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Related Devices (Code: HWC)

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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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