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FDA 510(k)

SINGLE SIZE TENDON SPACER

K-Number: K000019 · 2000-03-29

ApplicantMedist International
Decision Date2000-03-29
Product CodeHXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINGLE SIZE TENDON SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Medist International. It received FDA 510(k) clearance on 2000-03-29 under 510(k) number K000019. 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 SINGLE SIZE TENDON SPACER?

SINGLE SIZE TENDON SPACER is a medical device that received FDA 510(k) clearance on 2000-03-29. The listed applicant is Medist International. The 510(k) number is K000019.

When did SINGLE SIZE TENDON SPACER receive FDA 510(k) clearance?

SINGLE SIZE TENDON SPACER received FDA 510(k) clearance on 2000-03-29, under 510(k) number K000019.

Who is the listed applicant for SINGLE SIZE TENDON SPACER?

The FDA 510(k) record lists Medist International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE SIZE TENDON SPACER?

The FDA product code for SINGLE SIZE TENDON SPACER is HXA.

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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 MedicalK973385OVAL SHAPESTechnical Products, Inc.K964359AVANTA ORTHOPAEDICS TENDON SPACERAvanta Orthopaedics, 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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