Apache GAC114

GUDID M719GAC1140

Fixed Stop Anchor Finisher

Genesys Orthopedics Systems LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M719GAC1140
• NIH Device Record Key: a500199e-0664-481d-92e9-4d680db9fc48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apache
• Version Model Number: 1
• Catalog Number: GAC114
• 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

Customer Support Contacts

• Phone: 5123817070
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719GAC1140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181295

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M719GAC1140]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-10
• Device Publish Date: 2020-01-02

On-Brand Devices [Apache]

• 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