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FDA 510(k)

ARTHREX MENISCAL DART SYSTEM

K-Number: K983577 · 1999-08-13

ApplicantArthrex, Inc.
Decision Date1999-08-13
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX MENISCAL DART SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K983577. 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 ARTHREX MENISCAL DART SYSTEM?

ARTHREX MENISCAL DART SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Arthrex, Inc.. The 510(k) number is K983577.

When did ARTHREX MENISCAL DART SYSTEM receive FDA 510(k) clearance?

ARTHREX MENISCAL DART SYSTEM received FDA 510(k) clearance on 1999-08-13, under 510(k) number K983577.

Who is the listed applicant for ARTHREX MENISCAL DART SYSTEM?

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 ARTHREX MENISCAL DART SYSTEM?

The FDA product code for ARTHREX MENISCAL DART SYSTEM 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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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