HyperFlex® Bunion Correction System

GUDID G559HF2131LFT0

Hyperflex Small-Large-Left - Titanium

HYPERFLEX MEDICAL INC.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: G559HF2131LFT0
• NIH Device Record Key: 9de82e8b-f2c8-4834-b8f4-2b7e7a903c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperFlex® Bunion Correction System
• Version Model Number: HF-2131-LFT
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G559HF2131LFT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252997

FDA Product Code

• HRS: Plate, 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: 2026-01-09
• Device Publish Date: 2026-01-01

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
• G559HF1030000: HyperFlex Reduction Clamp
• G559HF2910RT0: Sizer / K-wire Pack - Right
• G559HF2910LFT0: Sizer / K-wire Pack - Left
• G559HF29000: Screw Pack - Titanium
• G559HF2331RT0: Hyperflex Large-Large-Right - Titanium
• G559HF2331LFT0: Hyperflex Large-Large-Left - Titanium
• G559HF2321RT0: Hyperflex Large-Medium-Right - Titanium
• G559HF2321LFT0: Hyperflex Large-Medium-Left - Titanium
• G559HF2311RT0: Hyperflex Large-Small-Right - Titanium
• G559HF2311LFT0: Hyperflex Large-Small-Left - Titanium
• G559HF2231RT0: Hyperflex Medium-Large-Right - Titanium
• G559HF2231LFT0: Hyperflex Medium-Large-Left - Titanium
• G559HF2221RT0: Hyperflex Medium-Medium-Right - Titanium
• G559HF2221LFT0: Hyperflex Medium-Medium-Left - Titanium
• G559HF2211RT0: Hyperflex Medium-Small-Right - Titanium
• G559HF2211LFT0: Hyperflex Medium-Small-Left - Titanium
• G559HF2131RT0: Hyperflex Small-Large-Right - Titanium
• G559HF2131LFT0: Hyperflex Small-Large-Left - Titanium
• G559HF2121RT0: Hyperflex Small-Medium-Right - Titanium
• G559HF2121LFT0: Hyperflex Small-Medium-Left - Titanium
• G559HF2111RT0: Hyperflex Small-Small-Right - Titanium
• G559HF2111LFT0: Hyperflex Small-Small-Left - Titanium