Primary Device ID | M555916004608 |
NIH Device Record Key | 13cf7541-cba8-4c3d-915c-00e005509d5c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Valeo Spacer System |
Version Model Number | A |
Catalog Number | 91.600.4608 |
Company DUNS | 028629553 |
Company Name | AMEDICA CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com | |
Phone | 801-839-3500 |
customerservice@amedica.com |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Height | 8 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M555916004608 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
[M555916004608]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2019-06-07 |
Device Publish Date | 2017-12-29 |
M555916006713 | Valeo II C, 16x14 6° 13-14mm -0.5 Stop |
M555916006711 | Valeo II C, 16x14 6° 11-12mm -0.5 Stop |
M555916006709 | Valeo II C, 16x14 6° 9-10mm -0.5 Stop |
M555916006707 | Valeo II C, 16x14 6° 7-8mm -0.5 Stop |
M555916006705 | Valeo II C, 16x14 6° 5-6mm -0.5 Stop |
M555916006613 | Valeo II C, 14x12 6° 13-14mm -0.5 Stop |
M555916006611 | Valeo II C, 14x12 6° 11-12mm -0.5 Stop |
M555916006609 | Valeo II C, 14x12 6° 9-10mm -0.5 Stop |
M555916006607 | Valeo II C, 14x12 6° 7-8mm -0.5 Stop |
M555916006605 | Valeo II C, 14x12 6° 5-6mm -0.5 Stop |
M555916006213 | Valeo II C, 16x14 0° 13-14mm -0.5 Stop |
M555916006211 | Valeo II C, 16x14 0° 11-12mm -0.5 Stop |
M555916006209 | Valeo II C, 16x14 0° 9-10mm -0.5 Stop |
M555916006207 | Valeo II C, 16x14 0° 7-8mm -0.5 Stop |
M555916006205 | Valeo II C, 16x14 0° 5-6mm -0.5 Stop |
M555916006113 | Valeo II C, 14x12 0° 13-14mm -0.5 Stop |
M555916006111 | Valeo II C, 14x12 0° 11-12mm -0.5 Stop |
M555916006109 | Valeo II C, 14x12 0° 9-10mm -0.5 Stop |
M555916006107 | Valeo II C, 14x12 0° 7-8mm -0.5 Stop |
M555916006105 | Valeo II C, 14x12 0° 5-6mm -0.5 Stop |
M555916005014 | Valeo II Dual Convex Cervical Trial, 14mm |
M555916005013 | Valeo II Dual Convex Cervical Trial, 13mm |
M555916005012 | Valeo II Dual Convex Cervical Trial, 12mm |
M555916005011 | Valeo II Dual Convex Cervical Trial, 11mm |
M555916005010 | Valeo II Dual Convex Cervical Trial, 10mm |
M555916005009 | Valeo II Dual Convex Cervical Trial, 9mm |
M555916005008 | Valeo II Dual Convex Cervical Trial, 8mm |
M555916005007 | Valeo II Dual Convex Cervical Trial, 7mm |
M555916005006 | Valeo II Dual Convex Cervical Trial, 6mm |
M555916004614 | Valeo II 6° 14mm Dual Cervical Trial |
M555916004613 | Valeo II 6° 13mm Dual Cervical Trial |
M555916004612 | Valeo II 6° 12mm Dual Cervical Trial |
M555916004611 | Valeo II 6° 11mm Dual Cervical Trial |
M555916004610 | Valeo II 6° 10mm Dual Cervical Trial |
M555916004609 | Valeo II 6° 9mm Dual Cervical Trial |
M555916004608 | Valeo II 6° 8mm Dual Cervical Trial |
M555916004607 | Valeo II 6° 7mm Dual Cervical Trial |
M555916004606 | Valeo II 6° 6mm Dual Cervical Trial |
M555916004605 | Valeo II 6° 5mm Dual Cervical Trial |
M555916004014 | Valeo II 0° 14mm Dual Cervical Trial |
M555916004013 | Valeo II 0° 13mm Dual Cervical Trial |
M555916004012 | Valeo II 0° 12mm Dual Cervical Trial |
M555916004011 | Valeo II 0° 11mm Dual Cervical Trial |
M555916004010 | Valeo II 0° 10mm Dual Cervical Trial |
M555916004009 | Valeo II 0° 9mm Dual Cervical Trial |
M555916004008 | Valeo II 0° 8mm Dual Cervical Trial |
M555916004007 | Valeo II 0° 7mm Dual Cervical Trial |
M555916004006 | Valeo II 0° 6mm Dual Cervical Trial |
M555916004005 | Valeo II 0° 5mm Dual Cervical Trial |
M555916003014 | Valeo II Convex 14mm Dual Cervical Trial |