The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Modification To Valeo Vbr.
Device ID | K073505 |
510k Number | K073505 |
Device Name: | MODIFICATION TO VALEO VBR |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington, DC 20005 |
Contact | Adam Herder |
Correspondent | Adam Herder AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington, DC 20005 |
Product Code | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-13 |
Decision Date | 2008-01-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841732129740 | K073505 | 000 |