| Primary Device ID | M179GSIX10609500 |
| NIH Device Record Key | f347e93d-fada-4e55-be61-f1c45527c110 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sacroiliac Joint Fusion System |
| Version Model Number | 1 |
| Catalog Number | GSI-X106-095 |
| Company DUNS | 017921066 |
| Company Name | Genesys Orthopedics Systems LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M179GSIX10609500 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
[M179GSIX10609500]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-17 |
| Device Publish Date | 2024-09-09 |
| M719GSIAD070700 | 7.0mm x 70mm SI Anchor - Dual Thread |
| M719GSIAD070650 | 7.0mm x 65mm SI Anchor - Dual Thread |
| M719GSIAD070600 | 7.0mm x 60mm SI Anchor - Dual Thread |
| M719GSIAD070550 | 7.0mm x 55mm SI Anchor - Dual Thread |
| M719GSIAD070500 | 7.0mm x 50mm SI Anchor - Dual Thread |
| M719GSIAD070450 | 7.0mm x 45mm SI Anchor - Dual Thread |
| M719GSIAD070400 | 7.0mm x 40mm SI Anchor - Dual Thread |
| M719GSIAD070350 | 7.0mm x 35mm SI Anchor - Dual Thread |
| M719GSIAD070300 | 7.0mm x 30mm SI Anchor - Dual Thread |
| M719GSISD095550 | 9.5mm x 55mm SI Screw - Dual Thread |
| M719GSISD095500 | 9.5mm x 50mm SI Screw - Dual Thread |
| M719GSISD095450 | 9.5mm x 45mm SI Screw - Dual Thread |
| M719GSISD095400 | 9.5mm x 40mm SI Screw - Dual Thread |
| M719GSISD095350 | 9.5mm x 35mm SI Screw - Dual Thread |
| M719GSIAW085700 | 8.5mm x 70mm SI Anchor - Washer Head |
| M719GSIAW085650 | 8.5mm x 65mm SI Anchor - Washer Head |
| M719GSIAW085600 | 8.5mm x 60mm SI Anchor - Washer Head |
| M719GSIAW085550 | 8.5mm x 55mm SI Anchor - Washer Head |
| M719GSIAW085500 | 8.5mm x 50mm SI Anchor - Washer Head |
| M719GSIAW085450 | 8.5mm x 45mm SI Anchor - Washer Head |
| M719GSIAW085400 | 8.5mm x 40mm SI Anchor - Washer Head |
| M719GSIAW085350 | 8.5mm x 35mm SI Anchor - Washer Head |
| M719GSIAW085300 | 8.5mm x 30mm SI Anchor - Washer Head |
| M719GSIAW070700 | 7.0mm x 70mm SI Anchor - Washer Head |
| M719GSIAW070650 | 7.0mm x 65mm SI Anchor - Washer Head |
| M719GSIAW070600 | 7.0mm x 60mm SI Anchor - Washer Head |
| M719GSIAW070550 | 7.0mm x 55mm SI Anchor - Dual Thread |
| M719GSIAW070500 | 7.0mm x 50mm SI Anchor - Washer Head |
| M719GSIAW070450 | 7.0mm x 45mm SI Anchor - Washer Head |
| M719GSIAW070400 | 7.0mm x 40mm SI Anchor - Washer Head |
| M719GSIAW070350 | 7.0mm x 35mm SI Anchor - Washer Head |
| M719GSIAW070300 | 7.0mm x 30mm SI Anchor - Washer Head |
| M719GSIAD085700 | 8.5mm x 70mm SI Anchor - Dual Thread |
| M719GSIAD085650 | 8.5mm x 65mm SI Anchor - Dual Thread |
| M719GSIAD085600 | 8.5mm x 60mm SI Anchor - Dual Thread |
| M719GSIAD085550 | 8.5mm x 55mm SI Anchor - Dual Thread |
| M719GSIAD085500 | 8.5mm x 50mm SI Anchor - Dual Thread |
| M719GSIAD085450 | 8.5mm x 45mm SI Anchor - Dual Thread |
| M719GSIAD085400 | 8.5mm x 40mm SI Anchor - Dual Thread |
| M719GSIAD085350 | 8.5mm x 35mm SI Anchor - Dual Thread |
| M719GSIAD085300 | 8.5mm x 30mm SI Anchor - Dual Thread |
| M719GSISF135350 | 13.5mm x 35mm SI Screw - Full Thread |
| M719GSISF135300 | 13.5mm x 30mm SI Screw - Full Thread |
| M719GSISF115700 | 11.5mm x 70mm SI Screw - Full Thread |
| M719GSISF115650 | 11.5mm x 65mm SI Screw - Full Thread |
| M719GSISF115600 | 11.5mm x 60mm SI Screw - Full Thread |
| M719GSISF115550 | 11.5mm x 55mm SI Screw - Full Thread |
| M719GSISF115500 | 11.5mm x 50mm SI Screw - Full Thread |
| M719GSISF115450 | 11.5mm x 45mm SI Screw - Full Thread |
| M719GSISF115400 | 11.5mm x 40mm SI Screw - Full Thread |