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FDA 510(k)

PERIMETER C (Titanium) Spinal System

K-Number: K153438 · 2016-03-02

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-03-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERIMETER C (Titanium) Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-03-02 under approval number K153438. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIMETER C (Titanium) Spinal System?

PERIMETER C (Titanium) Spinal System is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K153438.

When was PERIMETER C (Titanium) Spinal System approved by the FDA?

PERIMETER C (Titanium) Spinal System received FDA 510(k) clearance on 2016-03-02, under approval number K153438.

What company makes PERIMETER C (Titanium) Spinal System?

PERIMETER C (Titanium) Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for PERIMETER C (Titanium) Spinal System?

The FDA product code for PERIMETER C (Titanium) Spinal System is ODP.

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Related PubMed Literature

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Other Devices by Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K160418PERIMETER Interbody Fusion Device

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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