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)

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)

K-Number: K131683 · 2013-06-27

ApplicantDepuy Mitek, Inc., A Johnson and Johnson Company
Decision Date2013-06-27
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, Inc., A Johnson and Johnson Company. It received FDA 510(k) clearance on 2013-06-27 under 510(k) number K131683. 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 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)?

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) is a medical device that received FDA 510(k) clearance on 2013-06-27. The listed applicant is Depuy Mitek, Inc., A Johnson and Johnson Company. The 510(k) number is K131683.

When did HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) receive FDA 510(k) clearance?

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) received FDA 510(k) clearance on 2013-06-27, under 510(k) number K131683.

Who is the listed applicant for HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)?

The FDA 510(k) record lists Depuy Mitek, Inc., A Johnson and Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)?

The FDA product code for HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) 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 Depuy Mitek, Inc., A Johnson and Johnson Company 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.

K123668ORTHOCORDK1221236-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED

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.

↑