Curiteva Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Curiteva, LLC

The following data is part of a premarket notification filed by Curiteva, Llc with the FDA for Curiteva Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K181562
• 510k Number: K181562
• Device Name: Curiteva Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Curiteva, LLC 25127 Will McComb Drive, Suite 100 Tanner, AL 35671
• Contact: Eric Linder
• Correspondent: Eric Linder; Curiteva, LLC 25127 Will McComb Drive, Suite 100 Tanner, AL 35671
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-06-14
• Decision Date: 2018-08-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B648C15402420	K181562	000
B648C15401160	K181562	000
B648C15401140	K181562	000
B648C15401120	K181562	000
B648C15401100	K181562	000
B648C15405720	K181562	000
B648C15405680	K181562	000
B648C15405640	K181562	000
B648C15405600	K181562	000
B648C15401180	K181562	000
B648C15401200	K181562	000
B648C15401220	K181562	000
B648C15402390	K181562	000
B648C15402360	K181562	000
B648C15402330	K181562	000
B648C15402300	K181562	000
B648C15402270	K181562	000
B648C15402240	K181562	000
B648C15401260	K181562	000
B648C15401240	K181562	000
B648C15404920	K181562	000
B648C15404880	K181562	000
B648C15405760	K181562	000
B648C154051040	K181562	000
B648C154051000	K181562	000
B648C1544518VSD0	K181562	000
B648C1544516VSD0	K181562	000
B648C1544514VSD0	K181562	000
B648C1544512VSD0	K181562	000
B648C1544510VST0	K181562	000
B648C15405800	K181562	000
B648C15405840	K181562	000
B648C15405880	K181562	000
B648C15404560	K181562	000
B648C15404520	K181562	000
B648C15404480	K181562	000
B648C15403690	K181562	000
B648C15403660	K181562	000
B648C15403360	K181562	000
B648C15405960	K181562	000
B648C15405920	K181562	000
B648C1544510FST0	K181562	000
B648C1544518VST0	K181562	000
B648C1544016VST0	K181562	000
B648C1544016VSD0	K181562	000
B648C1544016FST0	K181562	000
B648C1544016FSD0	K181562	000
B648C1544014VST0	K181562	000
B648C1544014VSD0	K181562	000
B648C1544014FST0	K181562	000
B648C1544014FSD0	K181562	000
B648C1544018FSD0	K181562	000
B648C1544018FST0	K181562	000
B648C1544018VSD0	K181562	000
B648C1544518FST0	K181562	000
B648C1544516VST0	K181562	000
B648C1544516FST0	K181562	000
B648C1544514VST0	K181562	000
B648C1544514FST0	K181562	000
B648C1544512VST0	K181562	000
B648C1544512FST0	K181562	000
B648C1544018VST0	K181562	000
B648C1544012VST0	K181562	000
B648C1544012VSD0	K181562	000
B648C15403570	K181562	000
B648C15403540	K181562	000
B648C15403510	K181562	000
B648C15403480	K181562	000
B648C15403450	K181562	000
B648C15403420	K181562	000
B648C15403390	K181562	000
B648C15402480	K181562	000
B648C15403600	K181562	000
B648C15403630	K181562	000
B648C15404600	K181562	000
B648C1544012FST0	K181562	000
B648C1544012FSD0	K181562	000
B648C15404840	K181562	000
B648C15404800	K181562	000
B648C15404760	K181562	000
B648C15404720	K181562	000
B648C15404680	K181562	000
B648C15404640	K181562	000
B648C15402450	K181562	000