Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K121682 |
Device Name |
ACTIVE SCREW BONE SCREW |
Applicant |
INTELLIGENT IMPLANT SYSTEMS, LLC |
3300 INTERNATIONAL AIRPORT |
DRIVE SUITE 1100 |
CHARLOTTE,
NC
28208
|
|
Applicant Contact |
MICHAEL J NUTT |
Correspondent |
INTELLIGENT IMPLANT SYSTEMS, LLC |
3300 INTERNATIONAL AIRPORT |
DRIVE SUITE 1100 |
CHARLOTTE,
NC
28208
|
|
Correspondent Contact |
MICHAEL J NUTT |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/07/2012 |
Decision Date | 10/04/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|