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)

PEEK CEMENT RESTRICTOR X-BOX

K-Number: K041583 · 2004-07-22

ApplicantInnovasis, Inc.
Decision Date2004-07-22
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

PEEK CEMENT RESTRICTOR X-BOX is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041583. 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 PEEK CEMENT RESTRICTOR X-BOX?

PEEK CEMENT RESTRICTOR X-BOX is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Innovasis, Inc.. The 510(k) number is K041583.

When did PEEK CEMENT RESTRICTOR X-BOX receive FDA 510(k) clearance?

PEEK CEMENT RESTRICTOR X-BOX received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041583.

Who is the listed applicant for PEEK CEMENT RESTRICTOR X-BOX?

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

What is the FDA product code for PEEK CEMENT RESTRICTOR X-BOX?

The FDA product code for PEEK CEMENT RESTRICTOR X-BOX 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 Innovasis, 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.

K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250182Innovasis Navigation InstrumentsK241276Vector™ Pedicle Screw SystemK231899HAtetracell™-C Titanium Cervical IBF SystemK223511Excella Navigation InstrumentsK223510Matrix HA Fusion Porous Cervical IBF System

View all 27 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.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.

↑