Primary Device ID | B707129410010060 |
NIH Device Record Key | 178a503c-357c-488e-89bd-7e086035677a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DUALXS T/PLIF 15 DEG x 8-11MM |
Version Model Number | 12941001006 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B707129410010060 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
[B707129410010060]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-17 |
Device Publish Date | 2023-07-07 |
B707129410010060 | Lordosis & Heights: 15° x 8-11mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Hei |
B707129410010120 | Lordosis & Heights: 15° x 8-11mm Collapsed Width (mm): 10 Expanded Width (mm): 20 Collapsed Hei |