Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K120493 |
Device Name |
MINI CANNULATED HEADED AND HEADLESS SCREW SET |
Applicant |
INSTRATEK, INC. |
15200 Middlebrook Dr Ste G |
Houston,
TX
77058
|
|
Applicant Contact |
Jeff Seavey |
Correspondent |
INSTRATEK, INC. |
15200 Middlebrook Dr Ste G |
Houston,
TX
77058
|
|
Correspondent Contact |
Jeff Seavey |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/17/2012 |
Decision Date | 05/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|