BRYAN CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Premarket Approval P060023 S004

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

Use of a new location for the porous coating process performed at the firm¿s supplier.

DeviceBRYAN CERVICAL DISC
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2012-12-13
Decision Date2013-01-11
PMAP060023
SupplementS004
Product CodeMJO
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132

Supplemental Filings

Supplement NumberDateSupplement Type
P060023Original 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 IDPMASupp
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
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00613994363824 P060023 001
00613994363787 P060023 001
00613994363794 P060023 001
00613994363800 P060023 001
00613994363640 P060023 001

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