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FDA 510(k)

PIONEER SPINOUS PROCESS FUSION PLATE

K-Number: K101525 · 2010-10-22

ApplicantPioneer Surgical Technology
Decision Date2010-10-22
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER SPINOUS PROCESS FUSION PLATE 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 2010-10-22 under 510(k) number K101525. 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 SPINOUS PROCESS FUSION PLATE?

PIONEER SPINOUS PROCESS FUSION PLATE is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K101525.

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

PIONEER SPINOUS PROCESS FUSION PLATE received FDA 510(k) clearance on 2010-10-22, under 510(k) number K101525.

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

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 SPINOUS PROCESS FUSION PLATE?

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

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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 MISK093692QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIESK093771QUANTUM/STREAMLINE TL MIS SPINAL SYSTEMK100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIESK100361NANOSS BONE VOID FILLER

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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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