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FDA 510(k)

TaperSet™ Hip System

K-Number: K252846 · 2025-11-20

Decision Date2025-11-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TaperSet™ Hip System is a medical device manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. It received FDA 510(k) clearance on 2025-11-20 under approval number K252846. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TaperSet™ Hip System?

TaperSet™ Hip System is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. The 510(k) number is K252846.

When was TaperSet™ Hip System approved by the FDA?

TaperSet™ Hip System received FDA 510(k) clearance on 2025-11-20, under approval number K252846.

What company makes TaperSet™ Hip System?

TaperSet™ Hip System is manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics.

What is the FDA product code for TaperSet™ Hip System?

The FDA product code for TaperSet™ Hip System is LPH.

Other Devices by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

Related Devices (Code: LPH)

Official Source

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