Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K192578 |
Device Name |
InCore TMT System |
Applicant |
Nextremity Solutions, Inc. |
210 North Buffalo Street |
Warsaw,
IN
46580
|
|
Applicant Contact |
Elise Fox |
Correspondent |
Nextremity Solutions, Inc. |
210 North Buffalo Street |
Warsaw,
IN
46580
|
|
Correspondent Contact |
Elise Fox |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/19/2019 |
Decision Date | 12/31/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|