| Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
|
|---|
| 510(K) Number |
K113756 |
|---|
| Models |
110-02-726/738,
130-03-726/738,
130-10-726/738,
140-01-729/738
|
| Device Name |
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA |
|---|
| Applicant |
| ENCORE MEDICAL, L.P. |
| 9800 metric blvd. |
|
austin,
TX
78758
|
|
| Contact |
teffany hutto |
| Regulation Number | 888.3560
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 12/21/2011 |
|---|
| Decision Date | 03/14/2012 |
|---|
| 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
|
|---|
|
|
