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)

MITEK 2GII MENISCAL REPAIR SYSTEM

K-Number: K002406 · 2001-02-15

ApplicantMitek Products
Decision Date2001-02-15
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK 2GII MENISCAL REPAIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Products. It received FDA 510(k) clearance on 2001-02-15 under 510(k) number K002406. 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 MITEK 2GII MENISCAL REPAIR SYSTEM?

MITEK 2GII MENISCAL REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-15. The listed applicant is Mitek Products. The 510(k) number is K002406.

When did MITEK 2GII MENISCAL REPAIR SYSTEM receive FDA 510(k) clearance?

MITEK 2GII MENISCAL REPAIR SYSTEM received FDA 510(k) clearance on 2001-02-15, under 510(k) number K002406.

Who is the listed applicant for MITEK 2GII MENISCAL REPAIR SYSTEM?

The FDA 510(k) record lists Mitek Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MITEK 2GII MENISCAL REPAIR SYSTEM?

The FDA product code for MITEK 2GII MENISCAL REPAIR SYSTEM 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 Mitek Products 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.

K013572MITEK BIOCRYL INTERFERENCE SCREWSK013781RIDIDFIX 2.7MM BTB CROSS PIN KITK002639BIOKNOTLESS ANCHORK010633RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEMK003076MITEK CUFFTACKK002422VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM

View all 30 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.

↑