| Primary Device ID | M719GAC111N0 |
| NIH Device Record Key | f2566934-6569-4c93-bdf3-2f446ae928b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apache AIS-C Standalone |
| Version Model Number | 1 |
| Catalog Number | GAC111-N |
| 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 | false |
| 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 | M719GAC111N0 [Primary] |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
[M719GAC111N0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-30 |
| Device Publish Date | 2021-09-22 |
| M719GAC119N0 | No Stop AIS-C SS Inserter Tip |
| M719GAC11940 | 4mm AIS-C SS Inserter Tip |
| M719GAC11930 | 3mm AIS-C SS Inserter Tip |
| M719GAC11920 | 2mm AIS-C SS Inserter Tip |
| M719GAC11910 | 1mm AIS-C SS Inserter Tip |
| M719GAC111SN0 | No Stop AIS-C Impaction Inserter Cartridge, Small |
| M719GAC111S40 | 4mm AIS-C Impaction Inserter Cartridge Tip, Small |
| M719GAC111S30 | 3mm AIS-C Impaction Inserter Cartridge Tip, Small |
| M719GAC111S20 | 2mm AIS-C Impaction Inserter Cartridge Tip, Small |
| M719GAC111S10 | 1mm AIS-C Impaction Inserter Cartridge Tip, Small |
| M719GAC111N0 | No Stop AIS-C Impaction Inserter Cartridge Tip, Hybrid |
| M719GAC111LN0 | No Stop AIS-C Impaction Inserter Cartridge Tip, Large |
| M719GAC111L40 | 4mm AIS-C Impaction Inserter Cartridge Tip, Large |
| M719GAC111L30 | 3mm AIS-C Impaction Inserter Cartridge Tip, Large |
| M719GAC111L20 | 2mm AIS-C Impaction Inserter Cartridge Tip, Large |
| M719GAC111L10 | 1mm AIS-C Impaction Inserter Cartridge Tip, Large |
| M719GAC11140 | 4mm AIS-C Impaction Inserter Cartridge Tip, Hybrid |
| M719GAC110W40 | Welded Standalone Impaction Inserter - 4mm Stop |
| M719GAC110W30 | Welded Standalone Impaction Inserter - 3mm Stop |
| M719GAC110W20 | Welded Standalone Impaction Inserter - 2mm Stop |
| M719GAC110W10 | Welded Standalone Impaction Inserter - 1mm Stop |
| M719GAC110TWN0 | Welded Standalone Impaction Inserter - Threaded, No Stop |
| M719GAC110TW40 | Welded Standalone Impaction Inserter - Threaded, 4mm Stop |
| M719GAC110TW30 | Welded Standalone Impaction Inserter - Threaded, 3mm Stop |
| M719GAC110TW20 | Welded Standalone Impaction Inserter - Threaded, 2mm Stop |
| M719GAC110TW10 | Welded Standalone Impaction Inserter - Threaded, 1mm Stop |
| M719GAC1101N0 | Welded Standalone Impaction Inserter - No Stop |
| M719G45080 | AIS-C Inserter Caddy Lid |
| M719G45070 | AIS-C Inserter Caddy |
| M719G45060 | AIS-C Tray |
| M719G45050 | Apache Anchored Cervical Lid |
| M719G45040 | Apache Anchored Cervical Case |
| M719G45030 | Nail Caddy Lid |
| M719G45020 | Nail Caddy |
| M719G45010 | Interbody Caddies Lid |
| M719G4500U0 | Interbody Caddy, Universal |
| M719G45000 | PEEK Implant Caddy |
| M719GAC300120 | 12mm Lordotic Cervical Double Trial |
| M719GAC300110 | 11mm Lordotic Cervical Double Trial |
| M719GAC300100 | 10mm Lordotic Cervical Double Trial |
| M719GAC300090 | 9mm Lordotic Cervical Double Trial |
| M719GAC300080 | 8mm Lordotic Cervical Double Trial |
| M719GAC300070 | 7mm Lordotic Cervical Double Trial |
| M719GAC300060 | 6mm Lordotic Cervical Double Trial |
| M719GAC300050 | 5mm Lordotic Cervical Double Trial |
| M719GAC11100 | 0mm AIS-C Impaction Inserter Cartridge Tip, Hybrid |
| M719G50150 | Additional Cervical Plate Caddy Lid |
| M719G50140 | Additional Cervical Plate Caddy |
| M719G45160 | Standalone Accessory Caddy Lid |
| M719G45150 | Standalone Accessory Caddy |