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)

TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

K-Number: K011007 · 2001-06-12

ApplicantArthrex, Inc.
Decision Date2001-06-12
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2001-06-12 under 510(k) number K011007. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55?

TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 is a medical device that received FDA 510(k) clearance on 2001-06-12. The listed applicant is Arthrex, Inc.. The 510(k) number is K011007.

When did TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 receive FDA 510(k) clearance?

TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 received FDA 510(k) clearance on 2001-06-12, under 510(k) number K011007.

Who is the listed applicant for TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55?

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 TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55?

The FDA product code for TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 is MBI.

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: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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.

↑