Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K181231 |
Device Name |
DePuy Synthes T-PAL Spacer System |
Applicant |
DePuy Synthes Spine |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
Heta Shah |
Correspondent |
DePuy Synthes |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Rozanne Shirley |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 05/09/2018 |
Decision Date | 12/06/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|