PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Pyramid +4 Anterior Lumbar Spine Plate System.

Pre-market Notification Details

• Device ID: K071416
• 510k Number: K071416
• Device Name: PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Christine Scifert
• Correspondent: Christine Scifert; MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-21
• Decision Date: 2007-11-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000888053	K071416	000
00763000885489	K071416	000
00763000885496	K071416	000
00613994284907	K071416	000
00613994284914	K071416	000
00613994284983	K071416	000
00613994285096	K071416	000
00613994285102	K071416	000
00613994285119	K071416	000
00613994285133	K071416	000
00613994285911	K071416	000
00613994285935	K071416	000
00613994285959	K071416	000
00613994285973	K071416	000
00613994286031	K071416	000
00613994286048	K071416	000
00763000885069	K071416	000
00763000884673	K071416	000
00763000884666	K071416	000
00763000888060	K071416	000
00763000888077	K071416	000
00763000888084	K071416	000
00763000888091	K071416	000
00763000888107	K071416	000
00763000888114	K071416	000
00763000888121	K071416	000
00763000888138	K071416	000
00763000888145	K071416	000
00763000674458	K071416	000
00763000679415	K071416	000
00763000679460	K071416	000
00763000679538	K071416	000
00763000679545	K071416	000
00763000884659	K071416	000
00613994286055	K071416	000
00613994286062	K071416	000
00613994922809	K071416	000
00613994922816	K071416	000
00613994922823	K071416	000
00613994922830	K071416	000
00613994922847	K071416	000
00613994922854	K071416	000
00613994922861	K071416	000
00613994922878	K071416	000
00613994922885	K071416	000
00613994922892	K071416	000
00613994922953	K071416	000
00613994922960	K071416	000
00613994922977	K071416	000
00613994922984	K071416	000
00613994922991	K071416	000
00613994922793	K071416	000
00613994922786	K071416	000
00613994922779	K071416	000
00613994286079	K071416	000
00613994286826	K071416	000
00613994607126	K071416	000
00613994666536	K071416	000
00613994666598	K071416	000
00613994666604	K071416	000
00613994666611	K071416	000
00613994681393	K071416	000
00613994681409	K071416	000
00613994681416	K071416	000
00613994681423	K071416	000
00613994681430	K071416	000
00613994681447	K071416	000
00613994681454	K071416	000
00613994922762	K071416	000
00613994923004	K071416	000