FDA 510(k)

PLATEAU SPACER SYSTEM TITANIUM

K-Number: K130630 · 2013-06-13

Decision Date2013-06-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PLATEAU SPACER SYSTEM TITANIUM is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2013-06-13 under 510(k) number K130630. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATEAU SPACER SYSTEM TITANIUM?

PLATEAU SPACER SYSTEM TITANIUM is a medical device that received FDA 510(k) clearance on 2013-06-13. The listed applicant is Life Spine, Inc.. The 510(k) number is K130630.

When did PLATEAU SPACER SYSTEM TITANIUM receive FDA 510(k) clearance?

PLATEAU SPACER SYSTEM TITANIUM received FDA 510(k) clearance on 2013-06-13, under 510(k) number K130630.

Who is the listed applicant for PLATEAU SPACER SYSTEM TITANIUM?

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

What is the FDA product code for PLATEAU SPACER SYSTEM TITANIUM?

The FDA product code for PLATEAU SPACER SYSTEM TITANIUM is MAX.

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Other records listing Life Spine, Inc. as applicant

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Related Devices (Code: MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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.