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FDA 510(k)

SPINAL STABILIZING SPHERE SYSTEM

K-Number: K063139 · 2007-04-04

ApplicantBiomet Spine
Decision Date2007-04-04
Product CodeNVR
DecisionUnknown

Device Summary

SPINAL STABILIZING SPHERE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine. It received FDA 510(k) clearance on 2007-04-04 under 510(k) number K063139. The device is classified under product code NVR. FDA Decision: Unknown.

Frequently Asked Questions

What is the SPINAL STABILIZING SPHERE SYSTEM?

SPINAL STABILIZING SPHERE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-04. The listed applicant is Biomet Spine. The 510(k) number is K063139.

When did SPINAL STABILIZING SPHERE SYSTEM receive FDA 510(k) clearance?

SPINAL STABILIZING SPHERE SYSTEM received FDA 510(k) clearance on 2007-04-04, under 510(k) number K063139.

Who is the listed applicant for SPINAL STABILIZING SPHERE SYSTEM?

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

What is the FDA product code for SPINAL STABILIZING SPHERE SYSTEM?

The FDA product code for SPINAL STABILIZING SPHERE SYSTEM is NVR.

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.

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Other records listing Biomet 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.

K152622Alta ACDF SystemK121130POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODSK112014ZYSTON STRAIGHT SPACER SYSTEMK103393POLARIS SPINAL SYSTEMK093629SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEMK0910675.5 POLARIS SPINAL SYSTEM

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Related Devices (Code: NVR)

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.

K073274SPINAL SPHERE SYSTEMLife SpineK073105PEEK SPINAL SPHERESInterbody Innovations, LlpK062992SPINAL SPHERESInterbody Innovations, LlpK060415MODIFICATION TO: SATELLITE SPINAL SYSTEMMedtronic Sofamor DanekK051320SATELLITE SPINAL SYSTEMMedtronic Sofamor Danek

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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