Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K200151 |
Device Name |
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee |
Applicant |
Zimmer, Inc. |
1800 W. Center Street |
Warsaw,
IN
46580
|
|
Applicant Contact |
Pankti Shah |
Correspondent |
Zimmer, Inc. |
1800 W. Center Street |
Warsaw,
IN
46580
|
|
Correspondent Contact |
Pankti Shah |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 01/22/2020 |
Decision Date | 03/17/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|