Device Classification Name |
Accessories, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K882871 |
Device Name |
CASF DRILL GUIDE DG 170 |
Applicant |
TERRAY MANUFACTURING, INC. |
24 MCGONIGAL ST. WEST |
ARNPRIOR |
ONTARIO K7S 1L8,
CA
|
|
Applicant Contact |
JUDY WILSON |
Correspondent |
TERRAY MANUFACTURING, INC. |
24 MCGONIGAL ST. WEST |
ARNPRIOR |
ONTARIO K7S 1L8,
CA
|
|
Correspondent Contact |
JUDY WILSON |
Regulation Number | 888.4540 |
Classification Product Code |
|
Date Received | 07/11/1988 |
Decision Date | 09/23/1988 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|