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)

RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM

K-Number: K010633 · 2001-05-09

ApplicantMitek Products
Decision Date2001-05-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIGIDFIX SOFT TISSUE ACL CROSSPIN 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 2001-05-09 under 510(k) number K010633. 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 RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM?

RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-09. The listed applicant is Mitek Products. The 510(k) number is K010633.

When did RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM receive FDA 510(k) clearance?

RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM received FDA 510(k) clearance on 2001-05-09, under 510(k) number K010633.

Who is the listed applicant for RIGIDFIX SOFT TISSUE ACL CROSSPIN 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 RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM?

The FDA product code for RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM 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 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 ANCHORK002406MITEK 2GII MENISCAL REPAIR SYSTEMK003076MITEK CUFFTACKK002422VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM

View all 30 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.

↑