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FDA 510(k)

ULNAR HEAD IMPLANT

K-Number: K010786 · 2001-04-11

ApplicantAvanta Orthopaedics, Inc.
Decision Date2001-04-11
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULNAR HEAD IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Avanta Orthopaedics, Inc.. It received FDA 510(k) clearance on 2001-04-11 under 510(k) number K010786. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULNAR HEAD IMPLANT?

ULNAR HEAD IMPLANT is a medical device that received FDA 510(k) clearance on 2001-04-11. The listed applicant is Avanta Orthopaedics, Inc.. The 510(k) number is K010786.

When did ULNAR HEAD IMPLANT receive FDA 510(k) clearance?

ULNAR HEAD IMPLANT received FDA 510(k) clearance on 2001-04-11, under 510(k) number K010786.

Who is the listed applicant for ULNAR HEAD IMPLANT?

The FDA 510(k) record lists Avanta Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULNAR HEAD IMPLANT?

The FDA product code for ULNAR HEAD IMPLANT is KXE.

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Other records listing Avanta Orthopaedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030881AVANTA CARPAL FUSION PLATING SYSTEMK021859WRIST IMPLANTK023604MODIFICATION TO RADIAL HEAD IMPLANTK013629FINGER JOINT PROSTHESISK011819RADIAL HEAD IMPLANTK010847K'FIX

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Related Devices (Code: KXE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLCK112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension OrthopedicK081025ISOELASTICURemi Sciences, Inc.K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK061146SBI ULNAR HEAD IMPLANTSmall Bone Innovations, Inc.K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC

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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