PMA P960025S011
- Device
- SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE
- Applicant
- Depuy Spine, Inc.
- PMA number
- P960025
- Supplement
- S011
- Product code
- MCV
- Decision date
- 2004-03-05
- Classification
- Spinal Pedicle Screw, Fixation, Appliance System
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Approval order 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.
Current openFDA PMA Record#
- Device
- SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE
- Applicant
- Depuy Spine, Inc.
- PMA number
- P960025
- Supplement
- S011
- Product code
- MCV
- Generic name
- SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM
- Decision date
- 2004-03-05
- Decision code
- APPR
- Date received
- 2003-08-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.