The following data is part of a premarket notification filed by Ngmedical Gmbh with the FDA for Bee Plif Cage.
Device ID | K211413 |
510k Number | K211413 |
Device Name: | BEE PLIF Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | NGMedical GmbH Talsperrenblick 5 Nonnweiler, DE 66620 |
Contact | Stella Hahn |
Correspondent | Christine Scifert MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, CO 80112 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-06 |
Decision Date | 2021-08-27 |