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FDA 510(k)

SMALL STATURE SPACERS

K-Number: K063393 · 2007-06-25

ApplicantBiomet Spine
Decision Date2007-06-25
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMALL STATURE SPACERS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine. It received FDA 510(k) clearance on 2007-06-25 under 510(k) number K063393. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMALL STATURE SPACERS?

SMALL STATURE SPACERS is a medical device that received FDA 510(k) clearance on 2007-06-25. The listed applicant is Biomet Spine. The 510(k) number is K063393.

When did SMALL STATURE SPACERS receive FDA 510(k) clearance?

SMALL STATURE SPACERS received FDA 510(k) clearance on 2007-06-25, under 510(k) number K063393.

Who is the listed applicant for SMALL STATURE SPACERS?

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 SMALL STATURE SPACERS?

The FDA product code for SMALL STATURE SPACERS is MQP.

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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: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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