| Device Classification Name |
screw, fixation, bone
|
|---|
| 510(K) Number |
K121682 |
|---|
| Model |
107-4520, 107-4525, 107-4530, 107-4535, 107-4540, 1074545, 107-4550
|
| Device Name |
ACTIVE SCREW BONE SCREW |
|---|
| Applicant |
| INTELLIGENT IMPLANT SYSTEMS, LLC |
| 3300 international airport |
| drive suite 1100 |
|
charlotte,
NC
28208
|
|
| Contact |
michael j nutt |
| Regulation Number | 888.3040
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/07/2012 |
|---|
| Decision Date | 10/04/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
