Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K202298 |
Device Name |
Lucent XP, Lucent XP Curved |
Applicant |
Spinal Elements, Inc. |
3115 Melrose Dr. Suite 200 |
Carlsbad,
CA
92010
|
|
Applicant Contact |
Julie Lamothe |
Correspondent |
Spinal Elements, Inc. |
3115 Melrose Dr. Suite 200 |
Carlsbad,
CA
92010
|
|
Correspondent Contact |
Julie Lamothe |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 08/13/2020 |
Decision Date | 12/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|