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FDA 510(k)

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

K-Number: K131724 · 2013-12-24

ApplicantPioneer Surgical Technology, Inc.
Decision Date2013-12-24
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2013-12-24 under 510(k) number K131724. 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 MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE?

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2013-12-24. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K131724.

When did PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE receive FDA 510(k) clearance?

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE received FDA 510(k) clearance on 2013-12-24, under 510(k) number K131724.

Who is the listed applicant for PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE?

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

What is the FDA product code for PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE?

The FDA product code for PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE is MQP.

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Other records listing Pioneer Surgical Technology, Inc. as applicant

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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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