Device Classification Name |
Sacroiliac Joint Fixation
|
510(k) Number |
K180818 |
Device Name |
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) |
Applicant |
Tenon Medical, Inc. |
2100 Omega Road Suite F |
San Ramon,
CA
94583
|
|
Applicant Contact |
Kal Mentak |
Correspondent |
JGC, LLC |
2100 Omega Road, Suite F |
San Ramon,
CA
94583
|
|
Correspondent Contact |
Jeannie Cecka |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 03/29/2018 |
Decision Date | 06/13/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|