Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K111001 |
Device Name |
STERILE STORM (R) OPERATING KIT |
Applicant |
INTELLIGENT ORTHOPAEDICS LTD |
STAFFORDSHIRE UNIVERSITY |
BUSINESS VILLAGE, LEEK ROAD |
STOKE ON TRENT, STAFFORDSHIRE,
GB
ST4 2AR
|
|
Applicant Contact |
PETER J OGRODNIK |
Correspondent |
INTELLIGENT ORTHOPAEDICS LTD |
STAFFORDSHIRE UNIVERSITY |
BUSINESS VILLAGE, LEEK ROAD |
STOKE ON TRENT, STAFFORDSHIRE,
GB
ST4 2AR
|
|
Correspondent Contact |
PETER J OGRODNIK |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/11/2011 |
Decision Date | 05/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|