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FDA 510(k)

CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR

K-Number: K022615 · 2002-10-29

ApplicantCenterpulse Spine-Tech, Inc.
Decision Date2002-10-29
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Centerpulse Spine-Tech, Inc.. It received FDA 510(k) clearance on 2002-10-29 under 510(k) number K022615. 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 CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR?

CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2002-10-29. The listed applicant is Centerpulse Spine-Tech, Inc.. The 510(k) number is K022615.

When did CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR receive FDA 510(k) clearance?

CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR received FDA 510(k) clearance on 2002-10-29, under 510(k) number K022615.

Who is the listed applicant for CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR?

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

What is the FDA product code for CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR?

The FDA product code for CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR is JDK.

Related Clinical Trials

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Other records listing Centerpulse Spine-Tech, 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.

K033679COPSIOS BONE VOID FILLER (BVF)K031511DYNESYS SPINAL SYSTEMK022344TRINICA SELECT ANTERIOR CERVICAL PLATE 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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