Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K183249 |
Device Name |
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage |
Applicant |
STRYKER SPINE |
2 Pearl Court |
Allendale,
NJ
07401
|
|
Applicant Contact |
Deirdre Jayko |
Correspondent |
Stryker |
2 Pearl Court |
Allendale,
NJ
07401
|
|
Correspondent Contact |
Deirdre Jayko |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/21/2018 |
Decision Date | 07/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|