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FDA 510(k)

SPINAL USA CEMENT RESTRICTOR SYSTEM

K-Number: K060132 · 2006-03-16

ApplicantSpinal USA
Decision Date2006-03-16
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPINAL USA CEMENT RESTRICTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal USA. It received FDA 510(k) clearance on 2006-03-16 under 510(k) number K060132. 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 SPINAL USA CEMENT RESTRICTOR SYSTEM?

SPINAL USA CEMENT RESTRICTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Spinal USA. The 510(k) number is K060132.

When did SPINAL USA CEMENT RESTRICTOR SYSTEM receive FDA 510(k) clearance?

SPINAL USA CEMENT RESTRICTOR SYSTEM received FDA 510(k) clearance on 2006-03-16, under 510(k) number K060132.

Who is the listed applicant for SPINAL USA CEMENT RESTRICTOR SYSTEM?

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

What is the FDA product code for SPINAL USA CEMENT RESTRICTOR SYSTEM?

The FDA product code for SPINAL USA CEMENT RESTRICTOR SYSTEM is JDK.

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Other records listing Spinal USA 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.

K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICEK130863FACET SCREW SYSTEMK131343REFORM PEDICLE SCREW SYSTEMK130279REFORM PEDICLE SCREW SYSTEMK130445VAULT ALIF SYSTEMK122931S-LOK PSS SYSTEM

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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 SpineK051371INTERBODY 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.

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