Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K190231 |
Device Name |
InCore® Lapidus Sterile Kits |
Applicant |
Nextremity Solutions, Inc. |
210 North Buffalo Street |
Warsaw,
IN
46580
|
|
Applicant Contact |
Greg Denham |
Correspondent |
Nextremity Solutions, Inc. |
210 North Buffalo Street |
Warsaw,
IN
46580
|
|
Correspondent Contact |
Greg Denham |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/06/2019 |
Decision Date | 05/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|