Device Classification Name |
Filler, Bone Void, Calcium Compound
|
510(k) Number |
K190814 |
Device Name |
AccuFill Bone Substitute Material |
Applicant |
Zimmer Knee Creations |
841 Springdale Drive |
Exton,
PA
19341
|
|
Applicant Contact |
David l. Nichols |
Correspondent |
Mcra, LLC |
1050 K Street NW |
Suite 1000 |
Washington,
DC
20001
|
|
Correspondent Contact |
Hollace Saas Rhodes |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/29/2019 |
Decision Date | 06/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|