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FDA 510(k)

QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM

K-Number: K093771 · 2010-08-10

ApplicantPioneer Surgical Technology
Decision Date2010-08-10
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUANTUM/STREAMLINE TL MIS SPINAL 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 2010-08-10 under 510(k) number K093771. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM?

QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-10. The listed applicant is Pioneer Surgical Technology. The 510(k) number is K093771.

When did QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM receive FDA 510(k) clearance?

QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM received FDA 510(k) clearance on 2010-08-10, under 510(k) number K093771.

Who is the listed applicant for QUANTUM/STREAMLINE TL MIS SPINAL 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 QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM?

The FDA product code for QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM is MNH. This falls under the ENT category.

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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-SERIESK100708PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIESK100361NANOSS BONE VOID FILLER

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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