| Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
|---|
| 510(K) Number |
K120990 |
|---|
| Models |
00-5444-XXX-XX,00-5445-XXX-XX,
00-5446-XXX-XX,00-5447-XXX-XX
|
| Device Name |
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL |
|---|
| Applicant |
| ZIMMER TRABECULAR METAL TECHNOLOGY |
| 10 pomeroy rd. |
|
parsippany,
NJ
07054
|
|
| Contact |
judith rosen |
| Regulation Number | 888.3565
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 04/02/2012 |
|---|
| Decision Date | 06/29/2012 |
|---|
| 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
|
|---|
|
|
