The following data is part of a premarket notification filed by Amedica Corp. with the FDA for Valeo Pedicle Screw Spinal System.
| Device ID | K073430 |
| 510k Number | K073430 |
| 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 | 2007-12-06 |
| Decision Date | 2008-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M555110071040 | K073430 | 000 |
| M555110072125 | K073430 | 000 |
| M555110072150 | K073430 | 000 |
| M555110074525 | K073430 | 000 |
| M555110074530 | K073430 | 000 |
| M555110074535 | K073430 | 000 |
| M555110074540 | K073430 | 000 |
| M555110074545 | K073430 | 000 |
| M555110074550 | K073430 | 000 |
| M555110074555 | K073430 | 000 |
| M555110074560 | K073430 | 000 |
| M555110074565 | K073430 | 000 |
| M555110075001 | K073430 | 000 |
| M555110075530 | K073430 | 000 |
| M555110072100 | K073430 | 000 |
| M555110072080 | K073430 | 000 |
| M555110072070 | K073430 | 000 |
| M555110071050 | K073430 | 000 |
| M555110071060 | K073430 | 000 |
| M555110071070 | K073430 | 000 |
| M555110071080 | K073430 | 000 |
| M555110071100 | K073430 | 000 |
| M555110071125 | K073430 | 000 |
| M555110071150 | K073430 | 000 |
| M555110071200 | K073430 | 000 |
| M555110071300 | K073430 | 000 |
| M555110071500 | K073430 | 000 |
| M555110072040 | K073430 | 000 |
| M555110072050 | K073430 | 000 |
| M555110072060 | K073430 | 000 |
| M555110075535 | K073430 | 000 |
| M555110075540 | K073430 | 000 |
| M555110075545 | K073430 | 000 |
| M555110077540 | K073430 | 000 |
| M555110077545 | K073430 | 000 |
| M555110077550 | K073430 | 000 |
| M555110077555 | K073430 | 000 |
| M555110077560 | K073430 | 000 |
| M555110077565 | K073430 | 000 |
| M555110078530 | K073430 | 000 |
| M555110078535 | K073430 | 000 |
| M555110078540 | K073430 | 000 |
| M555110078545 | K073430 | 000 |
| M555110078550 | K073430 | 000 |
| M555110078555 | K073430 | 000 |
| M555110078560 | K073430 | 000 |
| M555110077535 | K073430 | 000 |
| M555110077530 | K073430 | 000 |
| M555110076565 | K073430 | 000 |
| M555110075550 | K073430 | 000 |
| M555110075555 | K073430 | 000 |
| M555110075560 | K073430 | 000 |
| M555110075565 | K073430 | 000 |
| M555110075601 | K073430 | 000 |
| M555110076001 | K073430 | 000 |
| M555110076530 | K073430 | 000 |
| M555110076535 | K073430 | 000 |
| M555110076540 | K073430 | 000 |
| M555110076545 | K073430 | 000 |
| M555110076550 | K073430 | 000 |
| M555110076555 | K073430 | 000 |
| M555110076560 | K073430 | 000 |
| M555110078565 | K073430 | 000 |