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FDA 510(k)

NOVASPINE CEMENT RESTRICTOR NSCR

K-Number: K051607 · 2005-10-07

ApplicantNovaspine, LLC
Decision Date2005-10-07
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVASPINE CEMENT RESTRICTOR NSCR is the device name listed in this FDA 510(k) record. The listed applicant is Novaspine, LLC. It received FDA 510(k) clearance on 2005-10-07 under 510(k) number K051607. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVASPINE CEMENT RESTRICTOR NSCR?

NOVASPINE CEMENT RESTRICTOR NSCR is a medical device that received FDA 510(k) clearance on 2005-10-07. The listed applicant is Novaspine, LLC. The 510(k) number is K051607.

When did NOVASPINE CEMENT RESTRICTOR NSCR receive FDA 510(k) clearance?

NOVASPINE CEMENT RESTRICTOR NSCR received FDA 510(k) clearance on 2005-10-07, under 510(k) number K051607.

Who is the listed applicant for NOVASPINE CEMENT RESTRICTOR NSCR?

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

What is the FDA product code for NOVASPINE CEMENT RESTRICTOR NSCR?

The FDA product code for NOVASPINE CEMENT RESTRICTOR NSCR 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.

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 Novaspine, 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.

K062456NOVASPINE POWERED SUCTION PUMP PRO-1K061133SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S

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

View on FDA Database →

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

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