Device Classification Name |
intervertebral fusion device with bone graft, cervical
|
510(k) Number |
K200429 |
Device Name |
BEE Cages |
Applicant |
NGMedical GmbH |
Talsperrenblick 5 |
Nonnweiler,
DE
66620
|
|
Applicant Contact |
Stella Hahn |
Correspondent |
MRC Global |
9085 East Mineral Circle, Suite 110 |
Centennial,
CO
80112
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 02/21/2020 |
Decision Date | 01/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|