Spinal Pedicle Screw, Fixation, Appliance System
Basic Information
- Device Name
- Spinal Pedicle Screw, Fixation, Appliance System
- Trade Name
- SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE
- PMA Number
- P960025
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- MCV
- Generic Name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 5, 2004
- Date Received
- August 4, 2003
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE SABER LUMBER I/F CAGE. IN ADDITION, THIS SUPPLEMENT REQUESTED THE APPROVAL OF TWO NEW SIZES, WHICH WILL NOW BE MARKETED AS THE JAGUAR LUMBAR I/F CAGE. THESE DEVICES ARE INDICATED FOR AN OPEN POSTERIOR APPROACH USING AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO SPINAL LEVELS FROM L2-S1 WHOSE CONDITION REQUIRES THE USE OF INTERBODY FUSION COMBINED WITH POSTEROLATERAL FUSION (360 DEGREES FUSION) AND POSTERIOR PEDICLE SCREW FIXATION . THESE PATIENTS MAY HAVE HAD PREVIOUS NON-FUSION SPINAL SURGERY AT THE INVOLVED SPINAL LEVELS(S). DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCV | Spinal Pedicle Screw, Fixation, Appliance System | FDA class 3 | Unknown |