FDA.report

FORTIFY

Primary DI
00889095042894
Brand
FORTIFY
Company
GLOBUS MEDICAL, INC.
Model
151.051
Device description
FORTIFY 12mm Core, Height 19-25mm
Published
2015-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Product Code Classifications

CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889095042894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095042894008890950428948890950428940889095042894

GMDN Terms

TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes

TypeValueUnit
Depth12Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags

DUNS number
139105691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01
00889095782486CREO6200.14052019-08-01
00193982647650ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.31272026-02-10
00193982647667ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.37202026-02-10
00193982647674ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50212026-02-10
00193982647681ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50222026-02-10
00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
00193982534028ANTHEM1181.82032026-01-27
00193982534035ANTHEM1181.82042026-01-27
00193982534042ANTHEM1181.82052026-01-27
00193982534059ANTHEM1181.82062026-01-27
00193982534066ANTHEM1181.82072026-01-27
00193982534073ANTHEM1181.82082026-01-27

Other Devices Sharing Product Codes

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04052536212989ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536212996ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213009ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213016ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213023ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536212804Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212811Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212828Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212835Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212842Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212859Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212866Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212873Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212880Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212897Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212903Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212910Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212927Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212934Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212941Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212958Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212965Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212972Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
00763000857936T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-02-27
00810141048478Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048485Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048492Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048508Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048515Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048577Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26