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.
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.
| Device | BRYAN CERVICAL DISC PROSTHESIS |
| Classification Name | Prosthesis, Intervertebral Disc |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Date Received | 2006-06-29 |
| Decision Date | 2009-05-12 |
| Notice Date | 2009-05-27 |
| PMA | P060023 |
| Supplement | S |
| Product Code | MJO |
| Docket Number | 09M-0243 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| 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 |
| 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 |
| 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 |