| Primary Device ID | M719GHA20180 |
| NIH Device Record Key | 4b58fb39-658e-4c66-9744-d8eb2a7b44af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apache |
| Version Model Number | 1 |
| Catalog Number | GHA-20-18 |
| 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 |
| Phone | 512-381-7070 |
| info@genesysspine.com |
| Angle | 18 degree |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M719GHA20180 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M719GHA20180]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-12-31 |
| M719GP500S0 | Stick ALIF Inserter |
| M719GP100GS0 | Slide PLIF Inserter |
| M719GCV100S0 | Apache Anchored Cervical Inserter with Stop |
| M719GCV1000 | Apache Anchored Cervical Inserter |
| M719GAC11130 | 3mm AIS-C Impaction Inserter Cartridge |
| M719GAC11120 | 2mm AIS-C Impaction Inserter Cartridge |
| M719GAC11110 | 1mm AIS-C Impaction Inserter Cartridge |
| M719GAC110S0 | AIS-C Impaction Inserter Shaft |
| M719GAC1100 | AIS-C Impaction Inserter |
| M719GAC1060 | AIS-C Anchor Extraction Screw |
| M719GAC1030 | AIS-C Anchor Extractor |
| M719GAC10130 | 3mm AIS-C Inserter Stop |
| M719GAC10120 | 2mm AIS-C Inserter Stop |
| M719GAC10110 | 1mm AIS-C Inserter Stop |
| M719GAC100XSDT0 | AIS-C Extra-Small Dovetail Inserter |
| M719GAC100XS0 | AIS-C X-Small Inserter |
| M719GAC100DT0 | AIS-C Dovetail Inserter |
| M719GAC1000 | AIS-C Inserter |
| M719GP5190 | Straight Curette #3 Cupped |
| M719GAC1200 | AIS-C Finishing Handle |
| M719GAC1140 | Fixed Stop Anchor Finisher |
| M719GAC110T0 | AIS-C Impaction Inserter, Threaded |
| M719GHA20S300 | Small Hyperlordotic ALIF 20mm x 30 DEG |
| M719GHA20S240 | Small Hyperlordotic ALIF 20mm x 24 DEG |
| M719GHA20S180 | Small Hyperlordotic ALIF 20mm x 18 DEG |
| M719GHA20L300 | Large Hyperlordotic ALIF 20mm x 30 DEG |
| M719GHA20L240 | Large Hyperlordotic ALIF 20mm x 24 DEG |
| M719GHA20L180 | Large Hyperlordotic ALIF 20mm x 18 DEG |
| M719GHA20300 | Medium Hyperlordotic ALIF 20mm x 30 DEG |
| M719GHA20240 | Medium Hyperlordotic ALIF 20mm x 14 DEG |
| M719GHA20180 | Medium Hyperlordotic ALIF 20mm x 18 DEG |
| M719GHA18S300 | Small Hyperlordotic ALIF 18mm x 30 DEG |
| M719GHA18S240 | Small Hyperlordotic ALIF 18mm x 24 DEG |
| M719GHA18S180 | Small Hyperlordotic ALIF 18mm x 18 DEG |
| M719GHA18L240 | Large Hyperlordotic ALIF 18mm x 24 DEG |
| M719GHA18L180 | Large Hyperlordotic ALIF 18mm x 18 DEG |
| M719GHA18300 | Medium Hyperlordotic ALIF 18mm x 30 DEG |
| M719GHA18240 | Medium Hyperlordotic ALIF 18mm x 24 DEG |
| M719GHA18180 | Medium Hyperlordotic ALIF 18mm x 18 DEG |
| M719GHA16S300 | Small Hyperlordotic ALIF 16mm x 30 DEG |
| M719GHA16S240 | Small Hyperlordotic ALIF 16mm x 24 DEG |
| M719GHA16S180 | Small Hyperlordotic ALIF 16mm x 18 DEG |
| M719GHA16L180 | Large Hyperlordotic ALIF 16mm x 18 DEG |
| M719GHA16240 | Medium Hyperlordotic ALIF 16mm x 24 DEG |
| M719GHA16180 | Medium Hyperlordotic ALIF 16mm x 18 DEG |
| M719GHA14S240 | Small Hyperlordotic ALIF 14mm x 24 DEG |
| M719GHA14S180 | Small Hyperlordotic ALIF 14mm x 18 DEG |
| M719GHA14L180 | Large Hyperlordotic ALIF 14mm x 18 DEG |
| M719GHA14180 | Medium Hyperlordotic ALIF 14mm x 18 DEG |
| M719GHA12S180 | Small Hyperlordotic ALIF 12mm x 18 DEG |