SI Joint GSI232

GUDID M719GSI2320

SI Ratcheting T-Handle with Impact Cap

Genesys Orthopedics Systems LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device IDM719GSI2320
NIH Device Record Key3a1577a4-c391-466f-9800-5505c0831358
Commercial Distribution StatusIn Commercial Distribution
Brand NameSI Joint
Version Model Number1
Catalog NumberGSI232
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

Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com
Phone512-381-7070
Emailinfo@genesysspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM719GSI2320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

[M719GSI2320]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-28
Device Publish Date2023-07-20

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M719GLL101L0 - 3DP Lumbar Interbody System2024-04-22 LLIF Angled Inserter - Left
M719GLL101R0 - 3DP Lumbar Interbody System2024-04-22 LLIF Angled Inserter - Right
M719GLL102M06000 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 6mm x 0-Degree
M719GLL102M08080 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 8mm x 8-Degree
M719GLL102M08150 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 8mm x 15-Degree
M719GLL102M10080 - 3DP Lumbar Interbody System2024-04-22 LLIF Ingot Trial, Medium 10mm x 8-Degree
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