FDA.reportPublic FDA data

SUSTAIN

Primary DI
00889095723267
Brand
SUSTAIN
Company
GLOBUS MEDICAL, INC.
Model
1145.4256
Device description
SUSTAIN-RT Titanium Spacer, 10x22mm, 16mm, 15°
Published
2019-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181357000PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.2018-12-06MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095723267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095723267008890957232678890957232670889095723267

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle15degree
Height16Millimeter
Length22Millimeter
Width10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849044040517N/A632.3002016-01-23
00193982662295ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00012026-03-30
00193982662301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00022026-03-30
00193982662318ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00032026-03-30
00193982662325ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00502026-03-30
00193982662332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00702026-03-30
00193982662349ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00902026-03-30
00193982662356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10502026-03-30
00193982662363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10702026-03-30
00193982662370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10902026-03-30
00193982662387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20502026-03-30
00193982662394ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20902026-03-30
00193982677411ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20702026-03-30
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02