Spinal Pedicle Screw, Fixation, Appliance System
Basic Information
- Device Name
- Spinal Pedicle Screw, Fixation, Appliance System
- Trade Name
- LUMBAR I/F CAGE SYSTEM
- PMA Number
- P960025
- Supplement Number
- S006
- 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
- May 14, 2001
- Date Received
- March 27, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Other
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE FOLLOWING FOUR CHANGES TO THE INVESTIGATIONAL PLAN (IP) FOR THE POSTAPPROVAL STUDY: 1) THE USE OF ADDITIONAL PEDICLE SCREW SPINAL SYSTEMS WITH THE I/F CAGE COMPONENT, I.E., TO ALLOW FOR TH EUSE OF THE TI ALLOY VERSION OF THE VSP SPINE SYSTEM, THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE ISOLA SPINE SYSTEM, THE TIMX SPINE SYSTEM AND THE TI ALLOY AND STAINLESS STEEL VERSIONS OF THE MOSS MIAMI SPINE SYSTEM IN ADDITION TO THE STAINLESS STEEL VERSION OF THE VSP SPINE SYSTEM; 2) A CHANGE IN THE NAME OF THE DEVICE SYSTEM TO BE EVALUATED IN THE POSTAPPROVAL STUDY TO BE CONSISTENT WITH THE RECENTLY APPROVED DEVICE SYSTEM NAME CHANGE; 3) A MODIFICATION OF THE INTRA-OP CASE REPORT FORM TO ALLOW INVESTIGATORS TO RECORD WHICH PEDICLE SCREW SPINAL SYSTEM IDENTIFIED IN ITEM 1 ABOVE WAS ACTUALLY IMPLANTED; AND 4) A CHANGE TO THE REQUIRED RADIOGRAPHIC ASSESSMENT METHODS, I.E., THE OPTIONAL USE OF T1-WEIGHTED MRI AND DISCOGRAPHY.
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 |