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FDA 510(k)

STREAMLINE MIS SPINAL FIXATION SYSTEM

K-Number: K130286 · 2013-04-01

ApplicantPioneer Surgical Technology, Inc.
Decision Date2013-04-01
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STREAMLINE MIS SPINAL FIXATION SYSTEM 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 2013-04-01 under 510(k) number K130286. 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 STREAMLINE MIS SPINAL FIXATION SYSTEM?

STREAMLINE MIS SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-01. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K130286.

When did STREAMLINE MIS SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

STREAMLINE MIS SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2013-04-01, under 510(k) number K130286.

Who is the listed applicant for STREAMLINE MIS SPINAL FIXATION SYSTEM?

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 STREAMLINE MIS SPINAL FIXATION SYSTEM?

The FDA product code for STREAMLINE MIS SPINAL FIXATION SYSTEM is NKB.

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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: 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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