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FDA 510(k)

SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM

K-Number: K094002 · 2010-05-07

ApplicantSpartek Medical, Inc.
Decision Date2010-05-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spartek Medical, Inc.. It received FDA 510(k) clearance on 2010-05-07 under 510(k) number K094002. 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 SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM?

SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-07. The listed applicant is Spartek Medical, Inc.. The 510(k) number is K094002.

When did SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM receive FDA 510(k) clearance?

SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM received FDA 510(k) clearance on 2010-05-07, under 510(k) number K094002.

Who is the listed applicant for SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM?

The FDA 510(k) record lists Spartek Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM?

The FDA product code for SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM is NKB.

Related Clinical Trials

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Other records listing Spartek Medical, 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.

K103383SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM

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

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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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