| Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
|---|
| 510(K) Number |
K122296 |
|---|
| Device Name |
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING |
|---|
| Applicant |
| SMITH & NEPHEW, INC. |
| 1450 brooks rd. |
|
memphis,
TN
38116
|
|
| Contact |
john connor |
| Regulation Number | 888.3353
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 07/31/2012 |
|---|
| Decision Date | 08/28/2012 |
|---|
| 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
|
|---|
|
|
