Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K180230 |
Device Name |
NEST Interbody System |
Applicant |
Paonan Biotech Co., Ltd. |
3F, No. 50, Lane 258, Rueiguang Rd. |
Neihu District |
Taipei City,
TW
11491
|
|
Applicant Contact |
Tony Lin |
Correspondent |
Paonan Biotech Co., Ltd. |
3F, No. 50, Lane 258, Rueiguang Rd. |
Neihu District |
Taipei City,
TW
11491
|
|
Correspondent Contact |
Tony Lin |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 01/26/2018 |
Decision Date | 01/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|