FDA 510(k)

SECULOK ACP System

K-Number: K182055 · 2018-09-10

Decision Date2018-09-10

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SECULOK ACP System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2018-09-10 under approval number K182055. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECULOK ACP System?

SECULOK ACP System is a medical device that received FDA 510(k) clearance on 2018-09-10. It is manufactured by U&I Corporation. The 510(k) number is K182055.

When was SECULOK ACP System approved by the FDA?

SECULOK ACP System received FDA 510(k) clearance on 2018-09-10, under approval number K182055.

What company makes SECULOK ACP System?

SECULOK ACP System is manufactured by U&I Corporation.

What is the FDA product code for SECULOK ACP System?

The FDA product code for SECULOK ACP System is KWQ.

Other Devices by U&I Corporation

K162189ANAX 5.5 Spinal System K173524ANAX 5.5 Spinal System K172419Velofix TLIF Cage K172424Velofix SA Cervical Cage K171749Velofix(tm) Interbody Fusion System K181824CBT Screw Fixation System

View all 16 devices →

Related Devices (Code: KWQ)

K160982SphynxEden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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.