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.

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• G559HF2111RT0 - HyperFlex® Bunion Correction System: 2026-01-09 Hyperflex Small-Small-Right - Titanium
• G559HF2121LFT0 - HyperFlex® Bunion Correction System: 2026-01-09 Hyperflex Small-Medium-Left - Titanium
• G559HF2121RT0 - HyperFlex® Bunion Correction System: 2026-01-09 Hyperflex Small-Medium-Right - Titanium
• G559HF2131LFT0 - HyperFlex® Bunion Correction System: 2026-01-09 Hyperflex Small-Large-Left - Titanium
• G559HF2131RT0 - HyperFlex® Bunion Correction System: 2026-01-09 Hyperflex Small-Large-Right - Titanium
• G559HF2211LFT0 - HyperFlex® Bunion Correction System: 2026-01-09 Hyperflex Medium-Small-Left - Titanium
• G559HF2211RT0 - HyperFlex® Bunion Correction System: 2026-01-09 Hyperflex Medium-Small-Right - Titanium