Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS

K-Number: K091844 · 2009-08-28

ApplicantArthrex, Inc.
Decision Date2009-08-28
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2009-08-28 under 510(k) number K091844. 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 BIO-COMPOSITE SUTURETAK ANCHORS?

ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS is a medical device that received FDA 510(k) clearance on 2009-08-28. The listed applicant is Arthrex, Inc.. The 510(k) number is K091844.

When did ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS receive FDA 510(k) clearance?

ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS received FDA 510(k) clearance on 2009-08-28, under 510(k) number K091844.

Who is the listed applicant for ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS?

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 BIO-COMPOSITE SUTURETAK ANCHORS?

The FDA product code for ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS is MAI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 330 devices →

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.

↑