BRYAN CERVICAL DISC PROSTHESIS

Prosthesis, Intervertebral Disc

FDA Premarket Approval P060023

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the bryan cervical disc. The device is indicated in skeletally mature patients for reconstruction of the disc from c3-c7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The bryan device is implanted via an open anterior approach. Intractable radiculopathyand/or myelopathy is defined as any combination of the following: disc herniation withradiculopathy. Spondylotic radiculopathy, disc herniation with myelopathy, or spondyloticmyelopathy resulting in impaired function and at least one clinical neurological sign associatedwith the cervical level to be treated, and necessitating surgery as demonstrated using computedtomography (ct), myelography and ct, and/or magnetic resonance imaging (mr1). Patientsreceiving the bryan cervical disc should have failed at least six weeks of non-operative treatment prior to implantation of the bryan cervical disc.

DeviceBRYAN CERVICAL DISC PROSTHESIS
Classification NameProsthesis, Intervertebral Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2006-06-29
Decision Date2009-05-12
Notice Date2009-05-27
PMAP060023
SupplementS
Product CodeMJO
Docket Number09M-0243
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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
00613994363633 P060023 001
00613994363824 P060023 001
00613994363787 P060023 001
00613994363794 P060023 001
00613994363800 P060023 001
00613994363640 P060023 001

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.