SpineWorks Anterior Lumbar Device A1630-11

GUDID M711A1630110

Innovasis, Inc.

Polymeric spinal interbody fusion cage
Primary Device IDM711A1630110
NIH Device Record Key7d7b9da9-60ec-4888-a6ca-54804186581e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpineWorks Anterior Lumbar Device
Version Model NumberA1630-11
Catalog NumberA1630-11
Company DUNS156567492
Company NameInnovasis, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Device Dimensions

Height16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM711A1630110 [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

[M711A1630110]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-04-15

On-Brand Devices [SpineWorks Anterior Lumbar Device]

M711A183060A1830-6
M711A1830110A1830-11
M711A182660A1826-6
M711A1826110A1826-11
M711A163060A1630-6
M711A1630110A1630-11
M711A162660A1626-6
M711A1626110A1626-11
M711A143060A1430-6
M711A1430110A1430-11
M711A142660A1426-6
M711A1426110A1426-11
M711A123060A1230-6
M711A1230110A1230-11
M711A122660A1226-6
M711A1226110A1226-11
M711A103060A1030-6
M711A1030110A1030-11
M711A102660A1026-6
M711A1026110A1026-11

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