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FDA 510(k)

AVANTA ORTHOPAEDICS TENDON SPACER

K-Number: K964359 · 1997-03-25

ApplicantAvanta Orthopaedics, Inc.
Decision Date1997-03-25
Product CodeHXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVANTA ORTHOPAEDICS TENDON SPACER 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 1997-03-25 under 510(k) number K964359. The device is classified under product code HXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVANTA ORTHOPAEDICS TENDON SPACER?

AVANTA ORTHOPAEDICS TENDON SPACER is a medical device that received FDA 510(k) clearance on 1997-03-25. The listed applicant is Avanta Orthopaedics, Inc.. The 510(k) number is K964359.

When did AVANTA ORTHOPAEDICS TENDON SPACER receive FDA 510(k) clearance?

AVANTA ORTHOPAEDICS TENDON SPACER received FDA 510(k) clearance on 1997-03-25, under 510(k) number K964359.

Who is the listed applicant for AVANTA ORTHOPAEDICS TENDON SPACER?

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 TENDON SPACER?

The FDA product code for AVANTA ORTHOPAEDICS TENDON SPACER is HXA.

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Other records listing Avanta Orthopaedics, Inc. as applicant

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K030881AVANTA CARPAL FUSION PLATING SYSTEMK021859WRIST IMPLANTK023604MODIFICATION TO RADIAL HEAD IMPLANTK013629FINGER JOINT PROSTHESISK010847K'FIXK011819RADIAL HEAD IMPLANT

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Related Devices (Code: HXA)

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.

K243477Universal Tendon SpacerAskorn MedicalK000019SINGLE SIZE TENDON SPACERMedist InternationalK973385OVAL SHAPESTechnical Products, Inc.K930125PHOENIX BONE SCREWS PBS-TYPE SERIESPhoenix Bioengineering, Inc.K872284H-H HUNTER ACTIVE TENDON IMPLANT PCHolter-Hausner Intl.K872285H-H HUNTER ACTIVE TENDON IMPLANT DCHolter-Hausner Intl.

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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