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FDA 510(k)

Streamline MIS Spinal Fixation System

K-Number: K192396 · 2019-11-26

ApplicantPioneer Surgical Technology, Inc.
Decision Date2019-11-26
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 2019-11-26 under 510(k) number K192396. 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 2019-11-26. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K192396.

When did Streamline MIS Spinal Fixation System receive FDA 510(k) clearance?

Streamline MIS Spinal Fixation System received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192396.

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.

Other records listing Pioneer Surgical Technology, Inc. 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.

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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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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