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FDA 510(k)

4CIS Marlin PEEK ACIF Cage

K-Number: K192044 · 2019-12-19

ApplicantSolco Biomedical Co., Ltd.
Decision Date2019-12-19
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS Marlin PEEK ACIF Cage is a medical device manufactured by Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under approval number K192044. 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 4CIS Marlin PEEK ACIF Cage?

4CIS Marlin PEEK ACIF Cage is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Solco Biomedical Co., Ltd.. The 510(k) number is K192044.

When was 4CIS Marlin PEEK ACIF Cage approved by the FDA?

4CIS Marlin PEEK ACIF Cage received FDA 510(k) clearance on 2019-12-19, under approval number K192044.

What company makes 4CIS Marlin PEEK ACIF Cage?

4CIS Marlin PEEK ACIF Cage is manufactured by Solco Biomedical Co., Ltd..

What is the FDA product code for 4CIS Marlin PEEK ACIF Cage?

The FDA product code for 4CIS Marlin PEEK ACIF Cage is ODP.

Other Devices by Solco Biomedical Co., Ltd.

K1624024CIS® Marlin ACIF Cage System K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage K1904714CIS® Chiron Spinal Fixation System K1824894CIS® Pinehurst Anterior Cervical Plate system K2032334CIS Chiron Spinal Fixation System K2316554CIS® Chiron Spinal Fixation 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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