HyperFlex® Bunion Correction System

GUDID G559FB29000

Pack:Stainless Steel:Screw Pack (SS) - 9mm

HYPERFLEX MEDICAL INC.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: G559FB29000
• NIH Device Record Key: 0a440c0a-6c85-428e-813b-409cc557b1a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperFlex® Bunion Correction System
• Version Model Number: FB-2900
• Company DUNS: 119512231
• Company Name: HYPERFLEX MEDICAL INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G559FB29000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241995

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-20
• Device Publish Date: 2025-06-12

On-Brand Devices [HyperFlex® Bunion Correction System]

• G559FB29900: Pack:Fixture Pack
• G559FB2910RT0: Pack:Sizer/K-wire Pack Right
• G559FB2910LFT0: Pack:Sizer/K-wire Pack Left
• G559FB29000: Pack:Stainless Steel:Screw Pack (SS) - 9mm
• G559FB2300RT0: Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Large - Right
• G559FB2300LFT0: "Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Large - Left"
• G559FB2200RT0: Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Medium - Right"
• G559FB2200LFT0: Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Medium - Left
• G559FB2100RT0: "Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Small - Right"
• G559FB2100LFT0: Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Small - Left
• G559FB2030RT0: Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Large - Right
• G559FB2030LFT0: Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Large - Left
• G559FB2020RT0: Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Medium - Right
• G559FB2020LFT0: Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Medium - Left
• G559FB2010RT0: Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack - Small - Right
• G559FB2010LFT0: Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack - Small - Left