MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
FDA premarket approval P110009 · decided 2013-08-23
Approval details
- PMA number
- P110009
- Trade name
- MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Highridge Medical, LLC
- Date received
- 2011-03-11
- Decision date
- 2013-08-23
- Days to decision
- 896 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminister, CO
- Statement
- APPROVAL FOR THE MOBI-C® CERVICAL DISC PROSTHESIS. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING DISCECTOMY AT TWO CONTIGUOUS LEVELS FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO ABNORMALITY LOCALIZED TO THE LEVEL OF THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLO
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510(k) clearances by this applicant
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| Vital™ Spinal Fixation System (K253093) | Highridge Medical, LLC | 2025-12-17 |
| Virage® OCT Spinal Fixation System (K250332) | Highridge Medical, LLC | 2025-04-04 |