Primary Device ID | M719GHA18S240 |
NIH Device Record Key | aeb3b631-a8db-42e7-9a62-6febfa22e462 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Apache |
Version Model Number | 1 |
Catalog Number | GHA-18-S24 |
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 | 24 degree |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M719GHA18S240 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M719GHA18S240]
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 |