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)

BIOFASTIN RC THREADED SUTURE ANCHOR

K-Number: K021883 · 2002-07-01

ApplicantMitek Worldwide
Decision Date2002-07-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFASTIN RC THREADED SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Worldwide. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K021883. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFASTIN RC THREADED SUTURE ANCHOR?

BIOFASTIN RC THREADED SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Mitek Worldwide. The 510(k) number is K021883.

When did BIOFASTIN RC THREADED SUTURE ANCHOR receive FDA 510(k) clearance?

BIOFASTIN RC THREADED SUTURE ANCHOR received FDA 510(k) clearance on 2002-07-01, under 510(k) number K021883.

Who is the listed applicant for BIOFASTIN RC THREADED SUTURE ANCHOR?

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

What is the FDA product code for BIOFASTIN RC THREADED SUTURE ANCHOR?

The FDA product code for BIOFASTIN RC THREADED SUTURE ANCHOR is HWC. This falls under the Cardiovascular category.

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 Worldwide 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.

K032717BIOCRYL RAPIDE INTERFERENCE SCREWK032167BIO-INTRAFIX TIBIAL SCREW AND SHEATHK032078MITEK MICRO QUICKANCHORK030995MINILOK QUICKANCHOR PLUSK031519CUFFLOK ANCHORK031406EXOJET TISSUE MANAGEMENT SYSTEM

View all 10 devices →

Related Devices (Code: HWC)

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 SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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.

↑