The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for Lp Cage.
Device ID | K110067 |
510k Number | K110067 |
Device Name: | LP CAGE |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | MEDYSSEY CO., LTD. 13540 GUILD AVE Apple Valley, MN 55124 |
Contact | Rich Jansen |
Correspondent | Rich Jansen MEDYSSEY CO., LTD. 13540 GUILD AVE Apple Valley, MN 55124 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-10 |
Decision Date | 2011-04-08 |
Summary: | summary |