CRESCENT™ Spinal System

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Crescent™ Spinal System.

Pre-market Notification Details

• Device ID: K171031
• 510k Number: K171031
• Device Name: CRESCENT™ Spinal System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Medtronic Sofamor Danek 1800 Pyramid Pl. Memphis, TN 38132
• Contact: Ankit K. Shah
• Correspondent: Ankit K. Shah; Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-06
• Decision Date: 2017-07-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169723368	K171031	000
00643169666054	K171031	000
00643169666047	K171031	000
00643169666030	K171031	000
00643169666023	K171031	000
00643169666016	K171031	000
00643169666009	K171031	000
00643169665996	K171031	000
00643169665989	K171031	000
00643169666061	K171031	000
00643169666078	K171031	000
00643169666085	K171031	000
00643169690912	K171031	000
00643169690905	K171031	000
00643169666146	K171031	000
00643169666139	K171031	000
00643169666122	K171031	000
00643169666115	K171031	000
00643169666108	K171031	000
00643169666092	K171031	000
00643169665972	K171031	000