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)

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR

K-Number: K061698 · 2006-07-12

ApplicantLife Spine
Decision Date2006-07-12
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine. It received FDA 510(k) clearance on 2006-07-12 under 510(k) number K061698. 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 MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR?

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2006-07-12. The listed applicant is Life Spine. The 510(k) number is K061698.

When did MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR receive FDA 510(k) clearance?

MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR received FDA 510(k) clearance on 2006-07-12, under 510(k) number K061698.

Who is the listed applicant for MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR?

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

What is the FDA product code for MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR?

The FDA product code for MODIFICATION TO LIFE SPINE 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.

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 Life Spine 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.

K182470Plateau Spacer SystemK160169The Life Spine Subtalar Implant SystemK131077LIFE SPINE PLATEAU SPACER SYSTEMK123373NAUTILUS SPINAL SYSTEMK120998SOLSTICE CROSS CONNECTORK111953NAUTILUS SPINAL SYSTEM

View all 33 devices →

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.K060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, LlpK051836SKELITE RESORBABLE CEMENT RESTRICTORMillenium Biologix, 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.

↑