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FDA 510(k)

TRAPEZIO-METACARPAL JOINT SPACER

K-Number: K790508 · 1979-04-10

ApplicantScientific Data Systems Israel, Ltd.
Decision Date1979-04-10
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRAPEZIO-METACARPAL JOINT SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Data Systems Israel, Ltd.. It received FDA 510(k) clearance on 1979-04-10 under 510(k) number K790508. 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 TRAPEZIO-METACARPAL JOINT SPACER?

TRAPEZIO-METACARPAL JOINT SPACER is a medical device that received FDA 510(k) clearance on 1979-04-10. The listed applicant is Scientific Data Systems Israel, Ltd.. The 510(k) number is K790508.

When did TRAPEZIO-METACARPAL JOINT SPACER receive FDA 510(k) clearance?

TRAPEZIO-METACARPAL JOINT SPACER received FDA 510(k) clearance on 1979-04-10, under 510(k) number K790508.

Who is the listed applicant for TRAPEZIO-METACARPAL JOINT SPACER?

The FDA 510(k) record lists Scientific Data Systems Israel, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAPEZIO-METACARPAL JOINT SPACER?

The FDA product code for TRAPEZIO-METACARPAL JOINT SPACER is KYI.

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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

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

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