Device Classification Name |
Staple, Fixation, Bone
|
510(k) Number |
K161426 |
Device Name |
NeoSpan Compression Staple Impant w/instruments |
Applicant |
IN2BONESUSA, LLC |
6060 POPLAR AVE, SUITE 380 |
MEMPHIS,
TN
38119
|
|
Applicant Contact |
JOE CLIFT |
Correspondent |
ENMED INTERNATIONAL, INC |
PO BOX 249 |
DEL MAR,
CA
92014
|
|
Correspondent Contact |
LOUISE FOCHT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 05/23/2016 |
Decision Date | 10/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|