FDA.reportPublic FDA data

SUSTAIN

Primary DI
00849044078381
Brand
SUSTAIN
Company
GLOBUS MEDICAL, INC.
Model
101.846
Device description
SUSTAIN Spacer, Medium, Narrow, Convex, 6mm
Published
2015-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849044078381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849044078381008490440783818490440783810849044078381

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
Depth11Millimeter
Height6Millimeter
Width12Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

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
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16
07640140433806icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2018-07-16
07640140433813icotec Cervical Cage, Anatomic Probe, 5 mm x 13 mmicotec AGODP2018-07-16
07640140433820icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mmicotec AGODP2018-07-16
07640140433837icotec Cervical Cage, Anatomic Probe, 7 mm x 13 mmicotec AGODP2018-07-16
07640140433875icotec Cervical Cage, Anatomic Probe, 5 mm x 16 mmicotec AGODP2018-07-16
07640140433882icotec Cervical Cage, Anatomic Probe, 6 mm x 16 mmicotec AGODP2018-07-16
07640140433899icotec Cervical Cage, Anatomic Probe, 7 mm x 16 mmicotec AGODP2018-07-16
07640140433905icotec Cervical Cage, Anatomic Probe, 8 mm x 16 mmicotec AGODP2018-07-16
07640140438900icotec Cervical Cage, Anatomic Probe, 5 mm x 18 mmicotec AGODP2018-07-16
07640140438917icotec Cervical Cage, Anatomic Probe, 6 mm x 18 mmicotec AGODP2018-07-16
07640140438924icotec Cervical Cage, Anatomic Probe, 7 mm x 18 mmicotec AGODP2018-07-16
07640140438931icotec Cervical Cage, Anatomic Probe, 8 mm x 18 mmicotec AGODP2018-07-16
07640140438948icotec Cervical Cage, Cervical Cage Anatomic, Container Rackicotec AGODP2018-07-16
07640164840949icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container, completeicotec AGODP2018-07-16
07640164840956icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container Baseicotec AGODP2018-07-16
07640164840963icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container Lidicotec AGODP2018-07-16
07640164840970icotec Lumbar Cage, Lumbar Cage ETurn TLIF, Container Inlay 1/2icotec AGODP2018-07-16
07640164840987icotec Lumbar Cage, Lumbar Cage PLIF, Container, completeicotec AGODP2018-07-16
07640164840994icotec Lumbar Cage, Lumbar Cage PLIF, Container Baseicotec AGODP2018-07-16
07640164841007icotec Lumbar Cage, Lumbar Cage PLIF, Container Lidicotec AGODP2018-07-16
07640164841014icotec Lumbar Cage, Lumbar Cage PLIF, Container Inlay 1/2icotec AGODP2018-07-16
07640164841342icotec Lumbar Cage, Extractoricotec AGODP2018-07-16
07640164841359icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 6 mmicotec AGODP2018-07-16
07640164841366icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 7 mmicotec AGODP2018-07-16
07640164841373icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 9 mmicotec AGODP2018-07-16
07640164841380icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 11 mmicotec AGODP2018-07-16
07640164841397icotec Lumbar Cage, Blade Distractor, Standard Shaft, Right Cutting, 13 mmicotec AGODP2018-07-16