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FDA 510(k)

Prase PEEK Anterior Cervical Interbody Spacer

K-Number: K202872 · 2021-02-04

ApplicantGbs Commonwealth Co., Ltd.
Decision Date2021-02-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prase PEEK Anterior Cervical Interbody Spacer is a medical device manufactured by Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2021-02-04 under approval number K202872. 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 Prase PEEK Anterior Cervical Interbody Spacer?

Prase PEEK Anterior Cervical Interbody Spacer is a medical device that received FDA 510(k) clearance on 2021-02-04. It is manufactured by Gbs Commonwealth Co., Ltd.. The 510(k) number is K202872.

When was Prase PEEK Anterior Cervical Interbody Spacer approved by the FDA?

Prase PEEK Anterior Cervical Interbody Spacer received FDA 510(k) clearance on 2021-02-04, under approval number K202872.

What company makes Prase PEEK Anterior Cervical Interbody Spacer?

Prase PEEK Anterior Cervical Interbody Spacer is manufactured by Gbs Commonwealth Co., Ltd..

What is the FDA product code for Prase PEEK Anterior Cervical Interbody Spacer?

The FDA product code for Prase PEEK Anterior Cervical Interbody Spacer is ODP.

Related Clinical Trials

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Other Devices by Gbs Commonwealth Co., Ltd.

K182059Prase MIS Spinal System K173645JASPER Spinal Fixation System K192026Peridot Intervertebral body fusion System K190762The JASPER Spinal Fixation System II K211205Prase-C Anterior Cervical Plate System K202878Prase-AP Anterior Cervical Plate 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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