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FDA 510(k)

Anatomical Plating System (various)

K-Number: K232652 · 2023-12-13

ApplicantTyber Medical, LLC
Decision Date2023-12-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anatomical Plating System (various) is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2023-12-13 under approval number K232652. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anatomical Plating System (various)?

Anatomical Plating System (various) is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Tyber Medical, LLC. The 510(k) number is K232652.

When was Anatomical Plating System (various) approved by the FDA?

Anatomical Plating System (various) received FDA 510(k) clearance on 2023-12-13, under approval number K232652.

What company makes Anatomical Plating System (various)?

Anatomical Plating System (various) is manufactured by Tyber Medical, LLC.

What is the FDA product code for Anatomical Plating System (various)?

The FDA product code for Anatomical Plating System (various) is HRS.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Tyber Medical, LLC

K161597Tyber Medical BioTy® Nanotopography Trauma Screw 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

View all 24 devices →

Related Devices (Code: HRS)

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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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