| Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
|---|
| 510(K) Number |
K122798 |
|---|
| Model |
186-00-48/68, 186-02-48/68
|
| Device Name |
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL |
|---|
| Applicant |
| EXACTECH, INC. |
| 2320 n.w. 66th ct. |
|
gainesville,
FL
32653
|
|
| Contact |
amy taulbee |
| Regulation Number | 888.3358
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 09/12/2012 |
|---|
| 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
|
|---|
|
|
