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FDA 510(k)

HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU

K-Number: K990361 · 1999-04-14

ApplicantArthrex, Inc.
Decision Date1999-04-14
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1999-04-14 under 510(k) number K990361. 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 HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU?

HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU is a medical device that received FDA 510(k) clearance on 1999-04-14. The listed applicant is Arthrex, Inc.. The 510(k) number is K990361.

When did HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU receive FDA 510(k) clearance?

HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU received FDA 510(k) clearance on 1999-04-14, under 510(k) number K990361.

Who is the listed applicant for HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU?

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 HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU?

The FDA product code for HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU is MAI.

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Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: MAI)

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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