The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Bn Lumbar Cage System.
Device ID | K140564 |
510k Number | K140564 |
Device Name: | BN LUMBAR CAGE SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | MEDYSSEY USA, INC. 11821 BRAMBLE COVE DR. Ft. Myers, FL 33905 |
Contact | Rich Jansen, Pharm D. |
Correspondent | Rich Jansen, Pharm D. MEDYSSEY USA, INC. 11821 BRAMBLE COVE DR. Ft. Myers, FL 33905 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-05 |
Decision Date | 2014-06-05 |
Summary: | summary |