SUSTAIN-IR

GUDID 00889095090543

SUSTAIN-IR Spacer, 9 x 26mm, 7°, 11mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage
Primary Device ID00889095090543
NIH Device Record Key963c8df0-c1cc-4d05-b0d0-6f11ac0b619d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSUSTAIN-IR
Version Model Number3145.1711
Company DUNS139105691
Company NameGLOBUS MEDICAL, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)930-1800
Emailinfo@globusmedical.com

Device Dimensions

Length26 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889095090543 [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

[00889095090543]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-10-09

On-Brand Devices [SUSTAIN-IR]

00889095303407Inserter Fork, Straight
00889095303391Inserter Fork, Straight, Short
00889095303360Inserter Fork
00889095303353Inserter Fork, Short
00889095303322Inserter Shaft
00889095093377SUSTAIN-IR Spacer, 9 x 34mm, 22°, 17mm
00889095093353SUSTAIN-IR Spacer, 9 x 34mm, 19°, 16mm
00889095093339SUSTAIN-IR Spacer, 9 x 34mm, 19°, 15mm
00889095093315SUSTAIN-IR Spacer, 9 x 30mm, 22°, 17mm
00889095093292SUSTAIN-IR Spacer, 9 x 30mm, 20°, 16mm
00889095093278SUSTAIN-IR Spacer, 9 x 30mm, 20°, 15mm
00889095093254SUSTAIN-IR Spacer, 9 x 30mm, 19°, 14mm
00889095093230SUSTAIN-IR Spacer, 9 x 30mm, 19°, 13mm
00889095093216SUSTAIN-IR Spacer, 9 x 26mm, 22°, 17mm
00889095093193SUSTAIN-IR Spacer, 9 x 26mm, 22°, 16mm
00889095093179SUSTAIN-IR Spacer, 9 x 26mm, 22°, 15mm
00889095093155SUSTAIN-IR Spacer, 9 x 22mm, 22°, 17mm
00889095093131SUSTAIN-IR Spacer, 9 x 22mm, 22°, 16mm
00889095093117SUSTAIN-IR Spacer, 9 x 22mm, 22°, 15mm
00889095093094SUSTAIN-IR Spacer, 9 x 22mm, 22°, 14mm
00889095093070SUSTAIN-IR Spacer, 9 x 22mm, 22°, 13mm
00889095093056SUSTAIN-IR Spacer, 9 x 22mm, 19°, 12mm
00889095092554SUSTAIN-IR Spacer, 9 x 34mm, 15°, 17mm
00889095092530SUSTAIN-IR Spacer, 9 x 34mm, 15°, 16mm
00889095092516SUSTAIN-IR Spacer, 9 x 34mm, 15°, 15mm
00889095092493SUSTAIN-IR Spacer, 9 x 34mm, 13°, 14mm
00889095092479SUSTAIN-IR Spacer, 9 x 34mm, 13°, 13mm
00889095092455SUSTAIN-IR Spacer, 9 x 34mm, 11°, 12mm
00889095092431SUSTAIN-IR Spacer, 9 x 34mm, 11°, 11mm
00889095092417SUSTAIN-IR Spacer, 9 x 30mm, 15°, 17mm
00889095092394SUSTAIN-IR Spacer, 9 x 30mm, 15°, 16mm
00889095092370SUSTAIN-IR Spacer, 9 x 30mm, 15°, 15mm
00889095092356SUSTAIN-IR Spacer, 9 x 30mm, 15°, 14mm
00889095092332SUSTAIN-IR Spacer, 9 x 30mm, 15°, 13mm
00889095092318SUSTAIN-IR Spacer, 9 x 30mm, 13°, 12mm
00889095092295SUSTAIN-IR Spacer, 9 x 30mm, 11°, 11mm
00889095092271SUSTAIN-IR Spacer, 9 x 30mm, 11°, 10mm
00889095092257SUSTAIN-IR Spacer, 9 x 26mm, 15°, 17mm
00889095092233SUSTAIN-IR Spacer, 9 x 26mm, 15°, 16mm
00889095092219SUSTAIN-IR Spacer, 9 x 26mm, 15°, 15mm
00889095092196SUSTAIN-IR Spacer, 9 x 26mm, 15°, 14mm
00889095092172SUSTAIN-IR Spacer, 9 x 26mm, 15°, 13mm
00889095092158SUSTAIN-IR Spacer, 9 x 26mm, 15°, 12mm
00889095092134SUSTAIN-IR Spacer, 9 x 26mm, 13°, 11mm
00889095092110SUSTAIN-IR Spacer, 9 x 26mm, 12°, 10mm
00889095092097SUSTAIN-IR Spacer, 9 x 22mm, 15°, 17mm
00889095092073SUSTAIN-IR Spacer, 9 x 22mm, 15°, 16mm
00889095092059SUSTAIN-IR Spacer, 9 x 22mm, 15°, 15mm
00889095092035SUSTAIN-IR Spacer, 9 x 22mm, 15°, 14mm
00889095092011SUSTAIN-IR Spacer, 9 x 22mm, 15°, 13mm

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