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FDA 510(k)

MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)

K-Number: K091499 · 2009-10-22

ApplicantKensey Nash Corp.
Decision Date2009-10-22
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corp.. It received FDA 510(k) clearance on 2009-10-22 under 510(k) number K091499. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)?

MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) is a medical device that received FDA 510(k) clearance on 2009-10-22. The listed applicant is Kensey Nash Corp.. The 510(k) number is K091499.

When did MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) receive FDA 510(k) clearance?

MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) received FDA 510(k) clearance on 2009-10-22, under 510(k) number K091499.

Who is the listed applicant for MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)?

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

What is the FDA product code for MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)?

The FDA product code for MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) is FTM.

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Other records listing Kensey Nash Corp. 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.

K103787MEDEOR MATRIXK091192KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XXK090919KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANEK073519QUICKCAT EXTRACTION CATHETER, MODEL 60090-01K071695KENSEY NASH MACROPORE SHIELDK072384MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE

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Related Devices (Code: FTM)

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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