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FDA 510(k)

PIONEER LOWTOP SPINAL ROD SYSTEM

K-Number: K080504 · 2008-03-20

ApplicantPioneer Surgical Technology
Decision Date2008-03-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIONEER LOWTOP SPINAL ROD SYSTEM 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 2008-03-20 under 510(k) number K080504. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIONEER LOWTOP SPINAL ROD SYSTEM?

PIONEER LOWTOP SPINAL ROD SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K080504.

When did PIONEER LOWTOP SPINAL ROD SYSTEM receive FDA 510(k) clearance?

PIONEER LOWTOP SPINAL ROD SYSTEM received FDA 510(k) clearance on 2008-03-20, under 510(k) number K080504.

Who is the listed applicant for PIONEER LOWTOP SPINAL ROD SYSTEM?

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 LOWTOP SPINAL ROD SYSTEM?

The FDA product code for PIONEER LOWTOP SPINAL ROD SYSTEM is NKB.

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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: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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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