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FDA 510(k)

Cervage

K-Number: K172568 · 2018-05-04

ApplicantPrecifit Medical, Ltd.
Decision Date2018-05-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervage is a medical device manufactured by Precifit Medical, Ltd.. It received FDA 510(k) clearance on 2018-05-04 under approval number K172568. 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 Cervage?

Cervage is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Precifit Medical, Ltd.. The 510(k) number is K172568.

When was Cervage approved by the FDA?

Cervage received FDA 510(k) clearance on 2018-05-04, under approval number K172568.

What company makes Cervage?

Cervage is manufactured by Precifit Medical, Ltd..

What is the FDA product code for Cervage?

The FDA product code for Cervage is ODP.

Other Devices by Precifit Medical, Ltd.

K171630LumFuse-TP K163327Precifit Medical Kirschner Wires K173189Lumfuse TP

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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