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FDA 510(k)

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS

K-Number: K092548 · 2009-12-15

ApplicantExtremity Medical, LLC
Decision Date2009-12-15
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K092548. 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 EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS?

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Extremity Medical, LLC. The 510(k) number is K092548.

When did EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS receive FDA 510(k) clearance?

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS received FDA 510(k) clearance on 2009-12-15, under 510(k) number K092548.

Who is the listed applicant for EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS?

The FDA 510(k) record lists Extremity Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS?

The FDA product code for EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS is KYI.

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Other records listing Extremity Medical, LLC as applicant

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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.

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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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