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FDA 510(k)

BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B

K-Number: K990987 · 2000-01-13

ApplicantArthrex, Inc.
Decision Date2000-01-13
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2000-01-13 under 510(k) number K990987. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B?

BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B is a medical device that received FDA 510(k) clearance on 2000-01-13. The listed applicant is Arthrex, Inc.. The 510(k) number is K990987.

When did BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B receive FDA 510(k) clearance?

BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B received FDA 510(k) clearance on 2000-01-13, under 510(k) number K990987.

Who is the listed applicant for BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B?

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

What is the FDA product code for BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B?

The FDA product code for BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B is MAI.

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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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