SuperScaffold™ 2265L3

GUDID M9632265L30

Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of findgers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol Intramedullary Fixation Scaffold (SuperScaffold™) implant held in place by use of a locking pin; 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.2mm Drill Bit with integral handle for manual use.

METRIC MEDICAL DEVICES, INC.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: M9632265L30
• NIH Device Record Key: c25b66a6-e743-41d7-a1d6-79fa80c1cc58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperScaffold™
• Version Model Number: 2265L3
• Catalog Number: 2265L3
• Company DUNS: 830255506
• Company Name: METRIC MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com
• Phone: 830.535.6300
• Email: sales@metricmd.com

Device Dimensions

• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 6.5 Millimeter
• Outer Diameter: 2.2 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)
• Special Storage Condition, Specify: Between 0 and 0 *Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9632265L30 [Primary]

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2018-04-25

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