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FDA 510(k)

AnyPlus® Cervical PEEK Cage System

K-Number: K153517 · 2016-06-24

ApplicantGS Medical Co., Ltd.
Decision Date2016-06-24
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AnyPlus® Cervical PEEK Cage System is a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under approval number K153517. 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 AnyPlus® Cervical PEEK Cage System?

AnyPlus® Cervical PEEK Cage System is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K153517.

When was AnyPlus® Cervical PEEK Cage System approved by the FDA?

AnyPlus® Cervical PEEK Cage System received FDA 510(k) clearance on 2016-06-24, under approval number K153517.

What company makes AnyPlus® Cervical PEEK Cage System?

AnyPlus® Cervical PEEK Cage System is manufactured by GS Medical Co., Ltd..

What is the FDA product code for AnyPlus® Cervical PEEK Cage System?

The FDA product code for AnyPlus® Cervical PEEK Cage System is ODP.

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Other Devices by GS Medical Co., Ltd.

K172546AnyPlus® Spinal Fixation System K192335TRACKER Kyphoplasty System K190170MVP Cervical Plate System K200592GS Medical AnyPlus PEEK Cage System K211797TRACKER Plus Kyphoplasty System K221687Pegasus-X Expandable PLIF System

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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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