| Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
|---|
| 510(K) Number |
K122463 |
|---|
| Models |
CM-2409,
CM-2410,
CM-2411
|
| Device Name |
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W |
|---|
| Applicant |
| CAYENNE MEDICAL, INC. |
| 16597 n. 92nd street |
| suite 101 |
|
scottsdale,
AZ
85260
|
|
| Contact |
kereshmeh shahriari |
| Regulation Number | 888.3040
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/13/2012 |
|---|
| Decision Date | 10/11/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
