The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Valeo Pedicle Screw Spinal System.
Device ID | K072022 |
510k Number | K072022 |
Device Name: | VALEO PEDICLE SCREW SPINAL SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington, DC 20005 |
Contact | Justin Eggleton |
Correspondent | Justin Eggleton AMEDICA CORP. 1331 H ST. NW, 12TH FLOOR Washington, DC 20005 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-23 |
Decision Date | 2007-11-19 |
Summary: | summary |