Ax®

GUDID M711LS3940

SST

Innovasis, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device IDM711LS3940
NIH Device Record Key4b8aa4ce-6393-4298-9d6a-08455a5def4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAx®
Version Model NumberLS-394
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
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
HIBCCM711LS3940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


[M711LS3940]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-08
Device Publish Date2022-03-31

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M711BTA1240Al, Nylon, Silicone
M711BTA1230Al, Nylon, Silicone
M711BTA1460Al, SST, Silicone
M711BTA1440Al, SST, Silicone
M711BTA1430Cross-linked Polyethylene, Convoluted Polyurethane, Lexan

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