FlareHawk FHTAS40027S

GUDID 03662663095105

11 mm or 14 mm x 27 mm, 0 degree, Split Shim

Highridge Medical, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 03662663095105
• NIH Device Record Key: 4a61b409-9a33-470c-9b46-20700be732a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlareHawk
• Version Model Number: FHTAS40027S
• Catalog Number: FHTAS40027S
• Company DUNS: 119260394
• Company Name: Highridge Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663095105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160076

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-03-20
• Device Publish Date: 2025-10-03

On-Brand Devices [FlareHawk]

• 03662663096980: FH Disc Prep Case
• 03662663096744: Modular 23mm Implant Caddy
• 03662663096737: Modular 27mm Implant Caddy
• 03662663096560: Shell Assembly Tall 33mm Version B
• 03662663096553: Shell Assembly Short 33mm Version B
• 03662663096546: 12mm or 14mm x 33mm Version B, 6 degree – Shim
• 03662663096539: 11mm or 13mm x 33mm Version B, 6 degree – Shim
• 03662663096522: 10mm or 12mm x 33mm Version B, 6 degree – Shim
• 03662663096515: 11mm or 14mm x 33mm Version B, 0 degree – Shim
• 03662663096508: 10mm or 13mm x 33mm Version B, 0 degree – Shim
• 03662663096492: 9mm or 12mm x 33mm Version B, 0 degree – Shim
• 03662663096485: 8mm or 11mm x 33mm Version B, 0 degree – Shim
• 03662663096478: FH Modular 27 Implant Caddy
• 03662663096461: FH Implant Case
• 03662663096454: Instrument Case
• 03662663096447: Expandable Trial Assembly, 8-14mm H, 9mm W, 0 degree
• 03662663096423: Expandable Trial Assembly, 8-14mm H, 9mm W, 6 degree
• 03662663096416: Insertion Instrument
• 03662663096263: K-Wire, Trocar Tip, 508mmL, FlareHawk 7
• 03662663096218: Shim, 11mm or 14mm x 30mm, 0 Degree, FlareHawk 7
• 03662663096195: Shim, 11mm or 14mm x 26mm, 0 Degree, FlareHawk 7
• 03662663096171: Shim, 10mm or 13mm x 30mm, 0 Degree, FlareHawk 7
• 03662663096157: Shim, 10mm or 13mm x 26mm, 0 Degree, FlareHawk 7
• 03662663096133: Shim 12mm or 14mm x 30mm 6 Degree FlareHawk 7
• 03662663096119: Shim, 12mm or 14mm x 26mm, 6 Degree, FlareHawk 7
• 03662663096096: Shim, 9mm or 12mm x 30mm, 0 Degree, FlareHawk 7
• 03662663096072: Shim 9mm or 12mm x 26mm 0 Degree FlareHawk 7
• 03662663096058: Shim, 11mm or 13mm x 30mm, 6 Degree, FlareHawk 7
• 03662663096034: Shim, 11mm or 13mm x 26mm, 6 Degree, FlareHawk 7
• 03662663096010: Shim, 8mm or 11mm x 30mm, 0 Degree, FlareHawk 7
• 03662663095990: Shim, 8mm or 11mm x 26mm, 0 Degree, FlareHawk 7
• 03662663095976: Shim, 10mm or 12mm x 30mm, 6 Degree, FlareHawk 7
• 03662663095952: Shim, 11mm or 14mm x 26mm, 0 Degree, FlareHawk 7
• 03662663095914: K Wire, Blunt Tip, 400mm, FH7 ENDO
• 03662663095907: K-Wire, Blunt Tip, 508mmL, FlareHawk 7
• 03662663095891: Guide Pin, FlareHawk 7
• 03662663095853: Shell, Tall 30mm, FlareHawk 7
• 03662663095815: Shell, Tall 26mm, FlareHawk 7
• 03662663095778: Shell, Short 30mm, FlareHawk 7
• 03662663095730: Shell, Short 26mm, FlareHawk 7
• 03662663095228: Shell, Lordotic Xtra Tall 29 mm, FlareHawk 9
• 03662663095211: Shell, Xtra Tall 29 mm, FlareHawk 9
• 03662663095204: Shim, 14mm or 16mm x 29 mm, 0 degree FlareHawk 9
• 03662663095198: Shim, 14mm or 16mm x 29 mm, 6 degree, FlareHawk 9
• 03662663095181: FlareHawk Shim, 14 or 16 mm x 29 mm, 6 degree Oblique
• 03662663095174: FlareHawk Shim, 14 or 16 mm x 25 mm, 6 degree Oblique
• 03662663095167: Shim, 13mm or 15mm x 29 mm, 0 degree, FlareHawk 9
• 03662663095150: Shim, 13mm or 15mm x 29 mm, 6 degree, FlareHawk 9
• 03662663095143: FlareHawk Shim, 13 or 15 mm x 29 mm, 6 degree Oblique
• 03662663095136: FlareHawk 9 Shim, 13mm or 15mm x 25 mm, 6 degree Oblique