Px® LS-211

GUDID M711LS2110

Silicone, SST

Innovasis, Inc.

Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver
Primary Device IDM711LS2110
NIH Device Record Key8700e0a6-46b9-4bfe-9b41-d316875f4b8f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePx®
Version Model NumberLS-211
Catalog NumberLS-211
Company DUNS156567492
Company NameInnovasis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM711LS2110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


[M711LS2110]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-11-10
Device Publish Date2019-07-05

On-Brand Devices [Px®]

M711LS1810Al, Silicone, SST
M711LS2630SST
M711BTA1180Crosslink Polyethylene, Convoluted Polyurethene, Lexan
M711LS26590SST
M711LS26580SST
M711LS265160SST
M711LS265150SST
M711LS265140SST
M711LS265130SST
M711LS265120SST
M711LS265110SST
M711LS265100SST
M711LS26490SST
M711LS26480SST
M711LS264160SST
M711LS264150SST
M711LS264140SST
M711LS264130SST
M711LS264120SST
M711LS264110SST
M711LS264100SST
M711LS26190SST
M711LS26180SST
M711LS261160SST
M711LS261150SST
M711LS261140SST
M711LS261130SST
M711LS261120SST
M711LS261110SST
M711LS261100SST
M711LS2580Silicone, SST
M711LS2110Silicone, SST
M711LS2160SST
M711LS2150Tecapro mt.
M711LS21090SST
M711LS21080SST
M711LS21070SST
M711LS210160SST
M711LS210150SST
M711LS210140SST
M711LS210130SST
M711LS210120SST
M711LS210110SST
M711LS210100SST
M711LS20990SST
M711LS20980SST
M711LS209160SST
M711LS209150SST
M711LS209140SST
M711LS209130SST

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.