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FDA 510(k)

MODIFICATION TO SYNTHES MATRIX SYSTEM

K-Number: K100952 · 2010-08-05

ApplicantSynthes Spine
Decision Date2010-08-05
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SYNTHES MATRIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2010-08-05 under 510(k) number K100952. 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 MODIFICATION TO SYNTHES MATRIX SYSTEM?

MODIFICATION TO SYNTHES MATRIX SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-05. The listed applicant is Synthes Spine. The 510(k) number is K100952.

When did MODIFICATION TO SYNTHES MATRIX SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SYNTHES MATRIX SYSTEM received FDA 510(k) clearance on 2010-08-05, under 510(k) number K100952.

Who is the listed applicant for MODIFICATION TO SYNTHES MATRIX SYSTEM?

The FDA 510(k) record lists Synthes Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO SYNTHES MATRIX SYSTEM?

The FDA product code for MODIFICATION TO SYNTHES MATRIX SYSTEM is NKB.

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Other records listing Synthes Spine 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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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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