SECURE-C ARTIFICIAL CERVICAL DISC
FDA premarket approval P100003 · decided 2012-09-28
Approval details
- PMA number
- P100003
- Trade name
- SECURE-C ARTIFICIAL CERVICAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Globus Medical, Inc.
- Date received
- 2010-01-29
- Decision date
- 2012-09-28
- Days to decision
- 973 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Audubon, PA
- Statement
- APPROVAL FOR THE SECURE-C ARTIFICIAL CERVICAL DISC. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OFTHE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE- LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVELABNORMALITY LOCALIZED TO THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPOND
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