Primary Device ID | B707128330070140 |
NIH Device Record Key | 0400cc05-8c74-4662-8679-0c37850c5ac5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KIT DUALX LLIF 10-13MM x 7 DEG x 55MM |
Version Model Number | 12833007014 |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B707128330070140 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2019-05-09 |
B70712833007014A0 | LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 55mm Lateral Width: 56.8 |
B707128330070140 | LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 55mm Collapsed Width (mm) |
B707128320070140 | LLIF IMPLANT - 7° x 22MM IMPLANTS Lordosis & Heights: 10-13mm x 7° x 55mm Collapsed Width (mm) |