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FDA 510(k)

AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT

K-Number: K964381 · 1997-01-22

ApplicantAvanta Orthopaedics, Inc.
Decision Date1997-01-22
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVANTA ORTHOPAEDICS TRAPEZIAL 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 1997-01-22 under 510(k) number K964381. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT?

AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Avanta Orthopaedics, Inc.. The 510(k) number is K964381.

When did AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT receive FDA 510(k) clearance?

AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964381.

Who is the listed applicant for AVANTA ORTHOPAEDICS TRAPEZIAL 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 AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT?

The FDA product code for AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT is KYI.

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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 PROSTHESISK010847K'FIXK011819RADIAL HEAD IMPLANT

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Related Devices (Code: KYI)

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.

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLCK180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLCK111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLCK112278ASCENSION NUGRIP CMC IMPLANTAscension OrthopedicK092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLCK061956ARTELON STT SPACERArtimplant AB

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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