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FDA 510(k)

THEKEN LARGE CEMENT RESTRICTOR

K-Number: K012462 · 2001-10-29

ApplicantTheken Surgical,Llc
Decision Date2001-10-29
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

THEKEN LARGE CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Theken Surgical,Llc. It received FDA 510(k) clearance on 2001-10-29 under 510(k) number K012462. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the THEKEN LARGE CEMENT RESTRICTOR?

THEKEN LARGE CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2001-10-29. The listed applicant is Theken Surgical,Llc. The 510(k) number is K012462.

When did THEKEN LARGE CEMENT RESTRICTOR receive FDA 510(k) clearance?

THEKEN LARGE CEMENT RESTRICTOR received FDA 510(k) clearance on 2001-10-29, under 510(k) number K012462.

Who is the listed applicant for THEKEN LARGE CEMENT RESTRICTOR?

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

What is the FDA product code for THEKEN LARGE CEMENT RESTRICTOR?

The FDA product code for THEKEN LARGE CEMENT RESTRICTOR is JDK.

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.

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Other records listing Theken Surgical,Llc 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.

K050058THEKEN REVEAL VBR SYSTEMK032064THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEMK012278THEKEN SMALL CEMENT RESTRICTORK010466TETHER ACFSK983622BODYFORM THORACO-LUMBAR FIXATION SYSTEM

Related Devices (Code: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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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