Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K061607 |
Device Name |
STORM OPERATING KIT, MODEL 1-10-0 |
Applicant |
INTELLIGENT ORTHOPAEDICS LTD |
BRIERFIELD MILL |
BRIERFIELD, NELSON,
GB
BB9 5NJ
|
|
Applicant Contact |
NEIL MC LACHLAN |
Correspondent |
INTELLIGENT ORTHOPAEDICS LTD |
BRIERFIELD MILL |
BRIERFIELD, NELSON,
GB
BB9 5NJ
|
|
Correspondent Contact |
NEIL MC LACHLAN |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2006 |
Decision Date | 07/18/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|