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FDA 510(k)

ARTELON STT SPACER

K-Number: K061956 · 2007-06-07

ApplicantArtimplant AB
Decision Date2007-06-07
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTELON STT SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Artimplant AB. It received FDA 510(k) clearance on 2007-06-07 under 510(k) number K061956. 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 ARTELON STT SPACER?

ARTELON STT SPACER is a medical device that received FDA 510(k) clearance on 2007-06-07. The listed applicant is Artimplant AB. The 510(k) number is K061956.

When did ARTELON STT SPACER receive FDA 510(k) clearance?

ARTELON STT SPACER received FDA 510(k) clearance on 2007-06-07, under 510(k) number K061956.

Who is the listed applicant for ARTELON STT SPACER?

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

What is the FDA product code for ARTELON STT SPACER?

The FDA product code for ARTELON STT SPACER is KYI.

Related Clinical Trials

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.

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Other records listing Artimplant AB 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.

K071887SPORTMESH OR ARTELON TISSUE REINFORCEMENTK061954ARTELON CMC SPACER ARTHROK052830SPORTMESHK052482ARTELON SURGICAL SUTUREK040070ARTELON SPACER CMC-1K032160ARTELON SURGICAL SUTURE

View all 7 devices →

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, LLCK061954ARTELON CMC SPACER ARTHROArtimplant 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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