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FDA 510(k)

NONLINEAR TAPER LAG SCREW

K-Number: K994382 · 2000-03-10

ApplicantTheken Surgical
Decision Date2000-03-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NONLINEAR TAPER LAG SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Theken Surgical. It received FDA 510(k) clearance on 2000-03-10 under 510(k) number K994382. 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 NONLINEAR TAPER LAG SCREW?

NONLINEAR TAPER LAG SCREW is a medical device that received FDA 510(k) clearance on 2000-03-10. The listed applicant is Theken Surgical. The 510(k) number is K994382.

When did NONLINEAR TAPER LAG SCREW receive FDA 510(k) clearance?

NONLINEAR TAPER LAG SCREW received FDA 510(k) clearance on 2000-03-10, under 510(k) number K994382.

Who is the listed applicant for NONLINEAR TAPER LAG SCREW?

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

What is the FDA product code for NONLINEAR TAPER LAG SCREW?

The FDA product code for NONLINEAR TAPER LAG 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 Theken Surgical 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.

K041592CORAL SPINAL SYSTEMK994383DOGBONE ACFS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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