Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K051044 |
Device Name |
ARCTEC SEMIRIGID PLATING SYSTEM |
Applicant |
ALTIVA CORP. |
9800-I SOUTHERN PINE BLVD. |
CHARLOTTE,
NC
28273
|
|
Applicant Contact |
JOHN KAPTIAN |
Correspondent |
ALTIVA CORP. |
9800-I SOUTHERN PINE BLVD. |
CHARLOTTE,
NC
28273
|
|
Correspondent Contact |
JOHN KAPTIAN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/25/2005 |
Decision Date | 10/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|