| Proprietary Name: |
APPLIANCE, FIXATION, SPINAL INTERLAMINALOrthosis, spondylolisthesis spinal fixationORTHOSIS, SPINAL PEDICLE FIXATION |
| Classification Name: |
ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION |
| Product Code: |
MNH |
| Device Class: |
2 |
| Regulation Number: |
888.3070 |
| Medical Specialty: |
Orthopedic |
| Registered Establishment Name: |
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)
|
| Registered Establishment Number: |
3001239363
|
| Premarket Submission Number: |
K010563 |
| Owner/Operator: |
3D Medical Manufacturing, inc. DBA Tecomet |
| Owner/Operator Number: |
10043250
|
| Establishment Operations: |
Contract Manufacturer
|