Sacroiliac Joint Fusion System GSI210-03

GUDID M719GSI210030

2-Pc Targeting Pin Tail - Extra Long

Genesys Orthopedics Systems LLC

Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile Intraoperative bone pin/screw, non-sterile
Primary Device IDM719GSI210030
NIH Device Record Key13d9a741-5ea5-403d-9bbc-7b66f1bf7b2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSacroiliac Joint Fusion System
Version Model Number1
Catalog NumberGSI210-03
Company DUNS017921066
Company NameGenesys Orthopedics Systems LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com
Phone5123817070
Emailinfo@genesysspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]
HIBCCM719GSI210030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation
OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


[M719GSI210030]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

On-Brand Devices [Sacroiliac Joint Fusion System]

M719GSIAD0707007.0mm x 70mm SI Anchor - Dual Thread
M719GSIAD0706507.0mm x 65mm SI Anchor - Dual Thread
M719GSIAD0706007.0mm x 60mm SI Anchor - Dual Thread
M719GSIAD0705507.0mm x 55mm SI Anchor - Dual Thread
M719GSIAD0705007.0mm x 50mm SI Anchor - Dual Thread
M719GSIAD0704507.0mm x 45mm SI Anchor - Dual Thread
M719GSIAD0704007.0mm x 40mm SI Anchor - Dual Thread
M719GSIAD0703507.0mm x 35mm SI Anchor - Dual Thread
M719GSIAD0703007.0mm x 30mm SI Anchor - Dual Thread
M719GSISD0955509.5mm x 55mm SI Screw - Dual Thread
M719GSISD0955009.5mm x 50mm SI Screw - Dual Thread
M719GSISD0954509.5mm x 45mm SI Screw - Dual Thread
M719GSISD0954009.5mm x 40mm SI Screw - Dual Thread
M719GSISD0953509.5mm x 35mm SI Screw - Dual Thread
M719GSIAW0857008.5mm x 70mm SI Anchor - Washer Head
M719GSIAW0856508.5mm x 65mm SI Anchor - Washer Head
M719GSIAW0856008.5mm x 60mm SI Anchor - Washer Head
M719GSIAW0855508.5mm x 55mm SI Anchor - Washer Head
M719GSIAW0855008.5mm x 50mm SI Anchor - Washer Head
M719GSIAW0854508.5mm x 45mm SI Anchor - Washer Head
M719GSIAW0854008.5mm x 40mm SI Anchor - Washer Head
M719GSIAW0853508.5mm x 35mm SI Anchor - Washer Head
M719GSIAW0853008.5mm x 30mm SI Anchor - Washer Head
M719GSIAW0707007.0mm x 70mm SI Anchor - Washer Head
M719GSIAW0706507.0mm x 65mm SI Anchor - Washer Head
M719GSIAW0706007.0mm x 60mm SI Anchor - Washer Head
M719GSIAW0705507.0mm x 55mm SI Anchor - Dual Thread
M719GSIAW0705007.0mm x 50mm SI Anchor - Washer Head
M719GSIAW0704507.0mm x 45mm SI Anchor - Washer Head
M719GSIAW0704007.0mm x 40mm SI Anchor - Washer Head
M719GSIAW0703507.0mm x 35mm SI Anchor - Washer Head
M719GSIAW0703007.0mm x 30mm SI Anchor - Washer Head
M719GSIAD0857008.5mm x 70mm SI Anchor - Dual Thread
M719GSIAD0856508.5mm x 65mm SI Anchor - Dual Thread
M719GSIAD0856008.5mm x 60mm SI Anchor - Dual Thread
M719GSIAD0855508.5mm x 55mm SI Anchor - Dual Thread
M719GSIAD0855008.5mm x 50mm SI Anchor - Dual Thread
M719GSIAD0854508.5mm x 45mm SI Anchor - Dual Thread
M719GSIAD0854008.5mm x 40mm SI Anchor - Dual Thread
M719GSIAD0853508.5mm x 35mm SI Anchor - Dual Thread
M719GSIAD0853008.5mm x 30mm SI Anchor - Dual Thread
M719GSISF13535013.5mm x 35mm SI Screw - Full Thread
M719GSISF13530013.5mm x 30mm SI Screw - Full Thread
M719GSISF11570011.5mm x 70mm SI Screw - Full Thread
M719GSISF11565011.5mm x 65mm SI Screw - Full Thread
M719GSISF11560011.5mm x 60mm SI Screw - Full Thread
M719GSISF11555011.5mm x 55mm SI Screw - Full Thread
M719GSISF11550011.5mm x 50mm SI Screw - Full Thread
M719GSISF11545011.5mm x 45mm SI Screw - Full Thread
M719GSISF11540011.5mm x 40mm SI Screw - Full Thread

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