Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K992168 |
Device Name |
MOSS MIAMI 6.35MM POLYAXIAL SCREW |
Applicant |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
FRANK MAAS |
Correspondent |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
FRANK MAAS |
Regulation Number | 888.3060
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/28/1999 |
Decision Date | 09/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|