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)

DARCO FORCE TITANIUM COMPRESSION SCREW

K-Number: K062103 · 2006-10-25

ApplicantDarco International, Inc.
Decision Date2006-10-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DARCO FORCE TITANIUM COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Darco International, Inc.. It received FDA 510(k) clearance on 2006-10-25 under 510(k) number K062103. 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 DARCO FORCE TITANIUM COMPRESSION SCREW?

DARCO FORCE TITANIUM COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 2006-10-25. The listed applicant is Darco International, Inc.. The 510(k) number is K062103.

When did DARCO FORCE TITANIUM COMPRESSION SCREW receive FDA 510(k) clearance?

DARCO FORCE TITANIUM COMPRESSION SCREW received FDA 510(k) clearance on 2006-10-25, under 510(k) number K062103.

Who is the listed applicant for DARCO FORCE TITANIUM COMPRESSION SCREW?

The FDA 510(k) record lists Darco International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DARCO FORCE TITANIUM COMPRESSION SCREW?

The FDA product code for DARCO FORCE TITANIUM COMPRESSION SCREW 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 Darco International, 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.

K061808DARCO LOCKING BONE PLATE SYSTEM

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.

↑