Primary Device ID | M719GSI2320 |
NIH Device Record Key | 3a1577a4-c391-466f-9800-5505c0831358 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SI Joint |
Version Model Number | 1 |
Catalog Number | GSI232 |
Company DUNS | 017921066 |
Company Name | Genesys Orthopedics Systems LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com | |
Phone | 512-381-7070 |
info@genesysspine.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M719GSI2320 [Primary] |
OUR | Sacroiliac Joint Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[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
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-28 |
Device Publish Date | 2023-07-20 |
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M719ACC830SM0 - Stasys-C Standalone PEEK | 2025-07-23 AIS-C II Cervical SA Anchor - Small |
M719ACC830XL0 - Stasys-C Standalone PEEK | 2025-07-23 AIS-C II Cervical SA Anchor - Extra Large |
M719ACC830XXL0 - Stasys-C Standalone PEEK | 2025-07-23 AIS-C II Cervical SA Anchor - Extra Extra Large |