FDA 510(k)

ARTELON SPACER CMC-1

K-Number: K040070 · 2004-09-21

Decision Date2004-09-21

Product CodeKYI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ARTELON SPACER CMC-1 is the device name listed in this FDA 510(k) record. The listed applicant is Artimplant AB. It received FDA 510(k) clearance on 2004-09-21 under 510(k) number K040070. 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 SPACER CMC-1?

ARTELON SPACER CMC-1 is a medical device that received FDA 510(k) clearance on 2004-09-21. The listed applicant is Artimplant AB. The 510(k) number is K040070.

When did ARTELON SPACER CMC-1 receive FDA 510(k) clearance?

ARTELON SPACER CMC-1 received FDA 510(k) clearance on 2004-09-21, under 510(k) number K040070.

Who is the listed applicant for ARTELON SPACER CMC-1?

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 SPACER CMC-1?

The FDA product code for ARTELON SPACER CMC-1 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

K071887SPORTMESH OR ARTELON TISSUE REINFORCEMENT K061956ARTELON STT SPACER K061954ARTELON CMC SPACER ARTHRO K052830SPORTMESH K052482ARTELON SURGICAL SUTURE K032160ARTELON SURGICAL SUTURE

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Related Devices (Code: KYI)

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC K180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLC K111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLC K112278ASCENSION NUGRIP CMC IMPLANTAscension Orthopedic K092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLC K061956ARTELON 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.