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FDA 510(k)

PIONEER SPINAL PROCESS FUSION PLATE

K-Number: K110367 · 2011-03-23

ApplicantPioneer Surgical Technology, Inc.
Decision Date2011-03-23
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER SPINAL PROCESS FUSION PLATE 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 2011-03-23 under 510(k) number K110367. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIONEER SPINAL PROCESS FUSION PLATE?

PIONEER SPINAL PROCESS FUSION PLATE is a medical device that received FDA 510(k) clearance on 2011-03-23. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K110367.

When did PIONEER SPINAL PROCESS FUSION PLATE receive FDA 510(k) clearance?

PIONEER SPINAL PROCESS FUSION PLATE received FDA 510(k) clearance on 2011-03-23, under 510(k) number K110367.

Who is the listed applicant for PIONEER SPINAL PROCESS FUSION PLATE?

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 SPINAL PROCESS FUSION PLATE?

The FDA product code for PIONEER SPINAL PROCESS FUSION PLATE is KWP.

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Other records listing Pioneer Surgical Technology, Inc. as applicant

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K261271Cable-Ready® Cable Grip SystemK251436Resolve Anterior Cervical Plate SystemK222493CODA™ Anterior Cervical Plate SystemK211408CervAlign® Anterior Cervical Plate SystemK192396Streamline MIS Spinal Fixation SystemK131724PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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