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FDA 510(k)

PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)

K-Number: K061151 · 2006-07-24

ApplicantPioneer Surgical Technology
Decision Date2006-07-24
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology. It received FDA 510(k) clearance on 2006-07-24 under 510(k) number K061151. 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 PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)?

PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) is a medical device that received FDA 510(k) clearance on 2006-07-24. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K061151.

When did PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) receive FDA 510(k) clearance?

PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) received FDA 510(k) clearance on 2006-07-24, under 510(k) number K061151.

Who is the listed applicant for PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)?

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

What is the FDA product code for PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)?

The FDA product code for PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) is MQP.

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Other records listing Pioneer Surgical Technology 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.

K110561FORTROSS BONE VOID FILLERK101790QUANTUM SPINAL SYSTEM, QUANTUM MISK101525PIONEER SPINOUS PROCESS FUSION PLATEK093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIESK093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEMK100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

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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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