Primary Device ID | B707125341260 |
NIH Device Record Key | 74e1c27e-ac99-48e1-a284-824cb437254e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | dualX Graft Delivery Tip (USA) |
Version Model Number | 12534126 |
Company DUNS | 081021000 |
Company Name | AMPLIFY SURGICAL, INC. |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com | |
Phone | 7652675439 |
udi@amplifysurgical.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B707125341260 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
[B707125341260]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-05-21 |
Device Publish Date | 2024-10-07 |
B707125341260 - dualX Graft Delivery Tip (USA) | 2025-05-21DUALX Graft Delivery Tip |
B707125341260 - dualX Graft Delivery Tip (USA) | 2025-05-21 DUALX Graft Delivery Tip |
B70712534146040 - DualX LLIF IMPLANT HOLDER 40mm | 2025-05-21 DUALX LLIF IMPLANT HOLDER 40mm |
B707125341460450 - DualX LLIF IMPLANT HOLDER 45mm | 2025-05-21 DUALX LLIF IMPLANT HOLDER 45mm |
B707125341460550 - DualX LLIF IMPLANT HOLDER 55mm | 2025-05-21 DUALX LLIF IMPLANT HOLDER 55mm |
B707128400060010 - DUALXS T/PLIF LOCKOUT SCREW SHORT | 2025-05-21 DUALXS T/PLIF LOCKOUT SCREW SHORT |
B707128450070 - DUALX LLIF IMPLANT STERILIZATION CADDY | 2025-05-21 LLIF IMPLANT STERILIZATION CADDY |
B707129410010010 - DUALXS T/PLIF 12 DEG x 7-10MM | 2025-05-21 Lordosis & Heights: 12° x 7-10mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Height (mm): 7 Expanded Height (mm) |
B707128300090010 - DUALX LLIF LOCKOUT SCREW 2 X 40MM | 2025-05-08 DUALX LLIF LOCKOUT SCREW 2 X 40MM |