The following data is part of a premarket notification filed by Amedica Corp with the FDA for Amedica Valeo Ii Interbody Fusion Device.
Device ID | K142347 |
510k Number | K142347 |
Device Name: | Amedica Valeo II Interbody Fusion Device |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Amedica Corp 1885 West 2100 South Salt Lake City, UT 84119 |
Contact | William D Jordan |
Correspondent | William D Jordan Amedica Corp 1885 West 2100 South Salt Lake City, UT 84119 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-22 |
Decision Date | 2014-11-18 |
Summary: | summary |