Company · US
Amedica Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2018. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 |
| MQP | Spinal Vertebral Body Replacement Device | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2018 | K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device Amedica Corp. | ODP |
| Nov 18, 2016 | K162160 | Preference Elite Pedicle Screw System Amedica Corporation | NKB |
| Aug 19, 2016 | K161405 | Valeo II Interbody Fusion Device System Amedica Corp. | MAX |
| Oct 2, 2015 | K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System Amedica Corp. | MAX |
| Dec 8, 2014 | K142264 | Valeo C Spacer System, Valeo II C IBF Device Amedica Corp. | ODP |
| Nov 18, 2014 | K142347 | Amedica Valeo II Interbody Fusion Device Amedica Corp. | MAX |
| Aug 24, 2012 | K121892 | PHANTOM PLUS CERAMIC CAGE SYSTEM Amedica Corp. | MAX |
| Jan 28, 2010 | K091278 | VALEO SPACER SYSTEM Amedica Corp. | MAX |
| Sep 26, 2008 | K082037 | SEEPLATE CERVICAL PLATE SYSTEM Amedica Corp. | KWQ |
| Jan 29, 2008 | K073430 | VALEO PEDICLE SCREW SPINAL SYSTEM Amedica Corp. | NKB |
| Jan 9, 2008 | K073505 | MODIFICATION TO VALEO VBR Amedica Corp. | MQP |
| Dec 5, 2007 | K073125 | VALEO VBR Amedica Corp. | MQP |
| Nov 19, 2007 | K072022 | VALEO PEDICLE SCREW SPINAL SYSTEM Amedica Corp. | NKB |
| Oct 29, 2007 | K071990 | VALEO CERVICAL PLATE SYSTEM Amedica Corp. | KWQ |
| Feb 17, 2006 | K051525 | ARX SPINAL SYSTEM Amedica Corp. | MQP |
| Apr 15, 2005 | K050699 | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 Amedica Corp. | JDK |
| Nov 14, 2002 | K022729 | VENTED CEMENT RESTRICTOR Amedica Corp. | JDX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||