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FDA 510(k)

MODIFICATION TO: ARTHREX INTERFERENCE SCREW

K-Number: K071176 · 2007-08-03

ApplicantArthrex, Inc.
Decision Date2007-08-03
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ARTHREX INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2007-08-03 under 510(k) number K071176. 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 MODIFICATION TO: ARTHREX INTERFERENCE SCREW?

MODIFICATION TO: ARTHREX INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2007-08-03. The listed applicant is Arthrex, Inc.. The 510(k) number is K071176.

When did MODIFICATION TO: ARTHREX INTERFERENCE SCREW receive FDA 510(k) clearance?

MODIFICATION TO: ARTHREX INTERFERENCE SCREW received FDA 510(k) clearance on 2007-08-03, under 510(k) number K071176.

Who is the listed applicant for MODIFICATION TO: ARTHREX INTERFERENCE SCREW?

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 MODIFICATION TO: ARTHREX INTERFERENCE SCREW?

The FDA product code for MODIFICATION TO: ARTHREX INTERFERENCE SCREW is MAI.

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Other records listing Arthrex, Inc. 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.

K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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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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