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FDA 510(k)

FIXIT Threaded Anchor System

K-Number: K170868 · 2017-11-30

ApplicantS.B.M Sas Science For Bio Materials
Decision Date2017-11-30
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXIT Threaded Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is S.B.M Sas Science For Bio Materials. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K170868. 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 FIXIT Threaded Anchor System?

FIXIT Threaded Anchor System is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is S.B.M Sas Science For Bio Materials. The 510(k) number is K170868.

When did FIXIT Threaded Anchor System receive FDA 510(k) clearance?

FIXIT Threaded Anchor System received FDA 510(k) clearance on 2017-11-30, under 510(k) number K170868.

Who is the listed applicant for FIXIT Threaded Anchor System?

The FDA 510(k) record lists S.B.M Sas Science For Bio Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXIT Threaded Anchor System?

The FDA product code for FIXIT Threaded Anchor System is MAI.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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