Primary Device ID | M719ACC10240 |
NIH Device Record Key | fdc4f047-35c1-46ec-9b6d-9edc09de8903 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AIS-C II Cervical Interbody System |
Version Model Number | 1 |
Catalog Number | ACC102-4 |
Company DUNS | 017921066 |
Company Name | Genesys Orthopedics Systems LLC |
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 | true |
OTC Over-The-Counter | false |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com | |
Phone | 5123817070 |
info@genesysspine.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M719ACC10240 [Primary] |
OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
[M719ACC10240]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-12 |
Device Publish Date | 2024-03-04 |
M719ACC102N0 | No Stop mm AIS-C II Inserter Tip |
M719ACC10240 | 4mm AIS-C II Inserter Tip |
M719ACC10230 | 3mm AIS-C II Inserter Tip |
M719ACC10220 | 2mm AIS-C II Inserter Tip |
M719ACC10210 | 1mm AIS-C II Inserter Tip |
M719ACC10200 | 0mm AIS-C II Inserter Tip |
M719ACC1000 | AIS-C II Cam Key |