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FDA 510(k)

Tyber Medical BioTy® Nanotopography Trauma Screw

K-Number: K161597 · 2016-11-16

ApplicantTyber Medical, LLC
Decision Date2016-11-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tyber Medical BioTy® Nanotopography Trauma Screw is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2016-11-16 under approval number K161597. 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® Nanotopography Trauma Screw?

Tyber Medical BioTy® Nanotopography Trauma Screw is a medical device that received FDA 510(k) clearance on 2016-11-16. It is manufactured by Tyber Medical, LLC. The 510(k) number is K161597.

When was Tyber Medical BioTy® Nanotopography Trauma Screw approved by the FDA?

Tyber Medical BioTy® Nanotopography Trauma Screw received FDA 510(k) clearance on 2016-11-16, under approval number K161597.

What company makes Tyber Medical BioTy® Nanotopography Trauma Screw?

Tyber Medical BioTy® Nanotopography Trauma Screw is manufactured by Tyber Medical, LLC.

What is the FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw?

The FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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

K153575Tyber Medical Trauma Screw K172185Tyber Medical PT Interbody Spacer System K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw K171327Tyber Medical Wedge System K180590Tyber Medical PT Interbody Spacer System K182284Tyber Medical PT Interbody Spacer

View all 24 devices →

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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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