BRYAN CERVICAL DISC SYSTEM

Prosthesis, Intervertebral Disc

FDA Premarket Approval P060023 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Site change for a manufacturing supplier.

• Device: BRYAN CERVICAL DISC SYSTEM
• Classification Name: Prosthesis, Intervertebral Disc
• Generic Name: Prosthesis, Intervertebral Disc
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Date Received: 2016-07-11
• Decision Date: 2016-08-11
• PMA: P060023
• Supplement: S005
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132

Supplemental Filings

Supplement Number	Date	Supplement Type
P060023		Original Filing
S008	2019-10-18	Normal 180 Day Track No User Fee
S007
S006	2017-07-13	Normal 180 Day Track No User Fee
S005	2016-07-11	30-day Notice
S004	2012-12-13	30-day Notice
S003	2012-05-04	135 Review Track For 30-day Notice
S002	2011-04-15	135 Review Track For 30-day Notice
S001	2010-05-18	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00613994365354	P060023	000
00613994181213	P060023	000
00613994181220	P060023	000
00613994181237	P060023	000
00613994181244	P060023	000
00613994181206	P060023	000
00613994365347	P060023	000
00613994365330	P060023	000
00613994365323	P060023	000
00613994365316	P060023	000
00613994363817	P060023	001
00613994360717	P060023	001
00613994363602	P060023	001
00613994363619	P060023	001
00613994363626	P060023	001
00613994363633	P060023	001
00613994363824	P060023	001
00613994363787	P060023	001
00613994363794	P060023	001
00613994363800	P060023	001
00613994363640	P060023	001