Primary Device ID | M711LS3950 |
NIH Device Record Key | 828a9fd6-a6bf-4aa8-8cac-8ca770ab6988 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tx™ |
Version Model Number | LS-395 |
Company DUNS | 156567492 |
Company Name | Innovasis, 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 | false |
Serial Number | true |
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 | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com | |
Phone | 801-261-2236 |
info@innovasis.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M711LS3950 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
[M711LS3950]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-11 |
Device Publish Date | 2022-04-01 |
M711LS4490 | SST |
M711LS3960 | SST, Silicone, PEEK |
M711LS3950 | Al, Silicone, SST |
M711BTA152010 | Polypropylene White, Radel Gray, Press-Fit W/SS |
M711BTA1510 | Al, SST, Silicone |
M711BTA1500 | Al, SST, Silicone |
M711BTA1490 | Al, SST, Silicone |
M711BTA1550 | Cross-linked Polyethylene, Convoluted Polyurethane, Lexan |
M711BTA1540 | Cross-linked Polyethylene, Convoluted Polyurethane, Lexan |
M711BTA153030 | Polypropylene White, Radel Gray, Press-Fit W/SS |
M711BTA153020 | Polypropylene White, Radel Gray, Press-Fit W/SS |
M711BTA153010 | Polypropylene White, Radel Gray, Press-Fit W/SS |
M711BTA152030 | Polypropylene White, Radel Gray, Press-Fit W/SS |
M711BTA152020 | Polypropylene White, Radel Gray, Press-Fit W/SS |
M711TX101428051 | HA PEEK, Ta |
M711TX101328121 | HA PEEK, Ta |
M711TX101328101 | HA PEEK, Ta |
M711TX101328051 | HA PEEK, Ta |
M711TX101228121 | HA PEEK, Ta |
M711TX101228101 | HA PEEK, Ta |
M711TX101228051 | HA PEEK, Ta |
M711TX101128121 | HA PEEK, Ta |
M711TX101128101 | HA PEEK, Ta |
M711TX101128051 | HA PEEK, Ta |
M711TX101028121 | HA PEEK, Ta |
M711TX101028101 | HA PEEK, Ta |
M711TX101028051 | HA PEEK, Ta |
M711TX100928121 | HA PEEK, Ta |
M711TX100928101 | HA PEEK, Ta |
M711TX100928051 | HA PEEK, Ta |
M711TX100828101 | HA PEEK, Ta |
M711TX100828051 | HA PEEK, Ta |
M711TX100728051 | HA PEEK, Ta |
M711TX121633101 | HA PEEK, Ta |
M711TX121633051 | HA PEEK, Ta |
M711TX121533121 | HA PEEK, Ta |
M711TX121533101 | HA PEEK, Ta |
M711TX121533051 | HA PEEK, Ta |
M711TX121433121 | HA PEEK, Ta |
M711TX121433101 | HA PEEK, Ta |
M711TX121433051 | HA PEEK, Ta |
M711TX121333121 | HA PEEK, Ta |
M711TX121333101 | HA PEEK, Ta |
M711TX121333051 | HA PEEK, Ta |
M711TX121233121 | HA PEEK, Ta |
M711TX121233101 | HA PEEK, Ta |
M711TX121233051 | HA PEEK, Ta |
M711TX121133121 | HA PEEK, Ta |
M711TX121133101 | HA PEEK, Ta |
M711TX121133051 | HA PEEK, Ta |