Boomerang™ Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

ChoiceSpine, LP

The following data is part of a premarket notification filed by Choicespine, Lp with the FDA for Boomerang™ Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K190227
• 510k Number: K190227
• Device Name: Boomerang™ Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: ChoiceSpine, LP 400 Erin Drive Knoxville, TN 37919
• Contact: Kim Finch
• Correspondent: Kim Finch; ChoiceSpine, LP 400 Erin Drive Knoxville, TN 37919
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-05
• Decision Date: 2019-05-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840996177658	K190227	000
00840996176484	K190227	000
00840996176477	K190227	000
00840996176460	K190227	000
00840996176453	K190227	000
00840996176446	K190227	000
00840996176439	K190227	000
00840996181242	K190227	000
00840996181235	K190227	000
00840996181228	K190227	000
00840996181211	K190227	000
00840996192392	K190227	000
00840996180160	K190227	000
00840996176491	K190227	000
00840996176507	K190227	000
00840996176682	K190227	000
00840996176675	K190227	000
00840996176668	K190227	000
00840996176651	K190227	000
00840996176644	K190227	000
00840996176637	K190227	000
00840996176620	K190227	000
00840996176613	K190227	000
00840996176545	K190227	000
00840996176538	K190227	000
00840996176521	K190227	000
00840996176514	K190227	000
00840996175760	K190227	000