Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K000590 |
Device Name |
LATERAL PIVOT INSERT |
Applicant |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Applicant Contact |
DEBBIE DE LOS SANTOS |
Correspondent |
ENCORE ORTHOPEDICS, INC. |
9800 METRIC BLVD. |
AUSTIN,
TX
78758
|
|
Correspondent Contact |
DEBBIE DE LOS SANTOS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 02/21/2000 |
Decision Date | 05/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|