Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K190544 |
Device Name |
XIHPOS™ ZFUZE™ Interbody Fusion System |
Applicant |
DiFusion Technologies |
1624 Headway Circle |
Austin,
TX
78754
|
|
Applicant Contact |
Derrick Johns |
Correspondent |
Hogan Lovells |
555 Thirteenth Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/04/2019 |
Decision Date | 11/01/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|