HyperFlex® Reduction Clamp

GUDID G559FB1030000

FootBridge Reduction Clamp

HYPERFLEX MEDICAL INC.

Hand-held surgical retractor, reusable

• Primary Device ID: G559FB1030000
• NIH Device Record Key: 65181449-c3b3-4f5b-9811-cb08f2501f78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperFlex® Reduction Clamp
• Version Model Number: FB-1030-00
• Company DUNS: 119512231
• Company Name: HYPERFLEX MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G559FB1030000 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

[G559FB1030000]

Moist Heat or Steam Sterilization

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

Devices Manufactured by HYPERFLEX MEDICAL INC.

• G559FB1030000 - HyperFlex® Reduction Clamp: 2025-06-20FootBridge Reduction Clamp
• G559FB1030000 - HyperFlex® Reduction Clamp: 2025-06-20 FootBridge Reduction Clamp
• G559FB2010LFT0 - HyperFlex® Bunion Correction System: 2025-06-20 Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack - Small - Left
• G559FB2010RT0 - HyperFlex® Bunion Correction System: 2025-06-20 Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack - Small - Right
• G559FB2020LFT0 - HyperFlex® Bunion Correction System: 2025-06-20 Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Medium - Left
• G559FB2020RT0 - HyperFlex® Bunion Correction System: 2025-06-20 Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Medium - Right
• G559FB2030LFT0 - HyperFlex® Bunion Correction System: 2025-06-20 Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Large - Left
• G559FB2030RT0 - HyperFlex® Bunion Correction System: 2025-06-20 Pack:Implant:Stainless Steel:2nd Met plate - Sterile Pack- Large - Right
• G559FB2100LFT0 - HyperFlex® Bunion Correction System: 2025-06-20 Pack:Implant:Stainless Steel:1st Met plate - Sterile Pack- Small - Left