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FDA 510(k)

MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM

K-Number: K080075 · 2008-01-28

ApplicantElite Surgical Supplies (Pty), Ltd.
Decision Date2008-01-28
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. It received FDA 510(k) clearance on 2008-01-28 under 510(k) number K080075. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM?

MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-28. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. The 510(k) number is K080075.

When did MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM received FDA 510(k) clearance on 2008-01-28, under 510(k) number K080075.

Who is the listed applicant for MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM?

The FDA 510(k) record lists Elite Surgical Supplies (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM?

The FDA product code for MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM is MNI.

Related Clinical Trials

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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Other records listing Elite Surgical Supplies (Pty), Ltd. 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.

K200523Biolign® Roto-Loc Cervical Plate SystemK130274BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEMK063453VERTEFIX PEDICLE SCREW SPINAL SYSTEM

Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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