SacroFuse

GUDID 00190361023388

Ø10MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 35MM

SPINEFRONTIER, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile
Primary Device ID00190361023388
NIH Device Record Key99cd0b61-755c-47f3-a1f1-b078c54533dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSacroFuse
Version Model Number01-42401-35
Company DUNS002003243
Company NameSPINEFRONTIER, 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

Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com
Phone+1(866)914-7717
Emailcustomerservice@spinefrontier.com

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter
Length35 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190361023388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac joint fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


[00190361023388]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-09
Device Publish Date2018-06-08

On-Brand Devices [SacroFuse]

00190361036289SCREW, SOLID WALL, CANNULATED, Ø12MM X 70MM, SACROFUSE
00190361036272SCREW, SOLID WALL, CANNULATED, Ø12MM X 65MM, SACROFUSE
00190361036265SCREW, SOLID WALL, CANNULATED, Ø12MM X 60MM, SACROFUSE
00190361036258SCREW, SOLID WALL, CANNULATED, Ø12MM X 55MM, SACROFUSE
00190361036241SCREW, SOLID WALL, CANNULATED, Ø12MM X 50MM, SACROFUSE
00190361036234SCREW, SOLID WALL, CANNULATED, Ø12MM X 45MM, SACROFUSE
00190361036227SCREW, SOLID WALL, CANNULATED, Ø12MM X 40MM, SACROFUSE
00190361036210SCREW, SOLID WALL, CANNULATED, Ø12MM X 35MM, SACROFUSE
00190361036203SCREW, SOLID WALL, CANNULATED, Ø12MM X 30MM, SACROFUSE
00190361036197SCREW, SOLID WALL, CANNULATED, Ø10MM X 70MM, SACROFUSE
00190361036180SCREW, SOLID WALL, CANNULATED, Ø10MM X 65MM, SACROFUSE
00190361036173SCREW, SOLID WALL, CANNULATED, Ø10MM X 60MM, SACROFUSE
00190361036166SCREW, SOLID WALL, CANNULATED, Ø10MM X 55MM, SACROFUSE
00190361036159SCREW, SOLID WALL, CANNULATED, Ø10MM X 50MM, SACROFUSE
00190361036142SCREW, SOLID WALL, CANNULATED, Ø10MM X 45MM, SACROFUSE
00190361036135SCREW, SOLID WALL, CANNULATED, Ø10MM X 40MM, SACROFUSE
00190361036128SCREW, SOLID WALL, CANNULATED, Ø10MM X 35MM, SACROFUSE
00190361036111SCREW, SOLID WALL, CANNULATED, Ø10MM X 30MM, SACROFUSE
00190361036104SCREW, SOLID WALL, CANNULATED, Ø8MM X 70MM, SACROFUSE
00190361036098SCREW, SOLID WALL, CANNULATED, Ø8MM X 65MM, SACROFUSE
00190361036081SCREW, SOLID WALL, CANNULATED, Ø8MM X 60MM, SACROFUSE
00190361036074SCREW, SOLID WALL, CANNULATED, Ø8MM X 55MM, SACROFUSE
00190361036067SCREW, SOLID WALL, CANNULATED, Ø8MM X 50MM, SACROFUSE
00190361036050SCREW, SOLID WALL, CANNULATED, Ø8MM X 45MM, SACROFUSE
00190361036043SCREW, SOLID WALL, CANNULATED, Ø8MM X 40MM, SACROFUSE
00190361036036SCREW, SOLID WALL, CANNULATED, Ø8MM X 35MM, SACROFUSE
00190361036029SCREW, SOLID WALL, CANNULATED, Ø8MM X 30MM, SACROFUSE
00190361036012FENESTRATED SCREW, CANNULATED, Ø10MM x 70MM, SACROFUSE
00190361036005FENESTRATED SCREW, CANNULATED, Ø10MM x 65MM, SACROFUSE
00190361035992FENESTRATED SCREW, CANNULATED, Ø10MM x 60MM, SACROFUSE
00190361035985FENESTRATED SCREW, CANNULATED, Ø10MM x 55MM, SACROFUSE
00190361035978FENESTRATED SCREW, CANNULATED, Ø10MM x 50MM, SACROFUSE
00190361035961FENESTRATED SCREW, CANNULATED, Ø10MM x 45MM, SACROFUSE
00190361035954FENESTRATED SCREW, CANNULATED, Ø10MM x 40MM, SACROFUSE
00190361035947FENESTRATED SCREW, CANNULATED, Ø10MM x 35MM, SACROFUSE
00190361035930FENESTRATED SCREW, CANNULATED, Ø10MM x 30MM, SACROFUSE
00190361035923FENESTRATED SCREW, CANNULATED, Ø12MM x 70MM, SACROFUSE
00190361035916FENESTRATED SCREW, CANNULATED, Ø12MM x 65MM, SACROFUSE
00190361035909FENESTRATED SCREW, CANNULATED, Ø12MM x 60MM, SACROFUSE
00190361035893FENESTRATED SCREW, CANNULATED, Ø12MM x 55MM, SACROFUSE
00190361035886FENESTRATED SCREW, CANNULATED, Ø12MM x 45MM, SACROFUSE
00190361035879FENESTRATED SCREW, CANNULATED, Ø12MM x 35MM, SACROFUSE
00190361035862FENESTRATED SCREW, CANNULATED, Ø12MM x 50MM, SACROFUSE
00190361035855FENESTRATED SCREW, CANNULATED, Ø12MM x 40MM, SACROFUSE
00190361035848FENESTRATED SCREW, CANNULATED, Ø12MM x 30MM, SACROFUSE
00190361023647DRIVER, GEN II INSERTER, SACROFUSE
00190361023630STYLET, GEN II INSERTER, SACROFUSE
00190361023623Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 70MM
00190361023616Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 65MM
00190361023609Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 60MM

Trademark Results [SacroFuse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SACROFUSE
SACROFUSE
86879981 5079908 Live/Registered
SpineFrontier, Inc.
2016-01-19

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