Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K040493 |
Device Name |
OUTOLOGOUS SPINAL FIXATION SYSTEM |
Applicant |
ORTHOPEDIC SCIENCES, INC |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
ORTHOPEDIC SCIENCES, INC |
4329 GRAYDON RD. |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/26/2004 |
Decision Date | 09/03/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|