Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K201193 |
Device Name |
SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSp |
Applicant |
SeaSpine Orthopedics Corporation |
5770 Armada Drive |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Alicia McArthur |
Correspondent |
SeaSpine Orthopedics Corporation |
5770 Armada Drive |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Jesse Albright |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/04/2020 |
Decision Date | 11/25/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|