DynaBridge DB-13-1010-A

GUDID 00819034023387

Superelastic Nitinol Implant Style A 15 x 12 x 12mm

FUSION ORTHOPEDICS, LLC

Orthopaedic bone staple, non-adjustable, non-sterile

• Primary Device ID: 00819034023387
• NIH Device Record Key: 4926c231-a87c-496b-ab64-2a6892ad5083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaBridge
• Version Model Number: DB-15-1212-A
• Catalog Number: DB-13-1010-A
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• 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: true
• 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
GS1	00819034023387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181815

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

[00819034023387]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-04-29

On-Brand Devices [DynaBridge]

• 00819034029273: Sizer Wheel Kit
• 00819034028016: Superelastic Nitinol Implant Style B 25mm x 20mm x 20mm
• 00819034028009: Superelastic Nitinol Implant Style B 20mm x 20mm x 20mm
• 00819034027996: Superelastic Nitinol Implant Style B 20mm x 15mm x 15mm
• 00819034027989: Superelastic Nitinol Implant Style B 18mm x 18mm x 15mm
• 00819034027972: Superelastic Nitinol Implant Style B 18mm x 18mm x 18mm
• 00819034027965: Superelastic Nitinol Implant Style B 18mm x 15mm x 15mm
• 00819034027958: Superelastic Nitinol Implant Style B 15mm x 15mm x 15mm
• 00819034027941: Superelastic Nitinol Implant Style B 15mm x 12mm x 12mm
• 00819034027934: Superelastic Nitinol Implant Style A 15mm x 12mm x 12mm
• 00819034027910: Superelastic Nitinol Implant Style A 13mm x 10mm x 10mm
• 00819034027897: Superelastic Nitinol Implant Style A 11mm x 10mm x 10mm
• 00819034027880: Superelastic Nitinol Implant Style A 9 x 8 x 8mm (Single)
• 00819034027873: Drill Guide Style B 25mm
• 00819034027866: Drill Guide Style B 20mm
• 00819034027859: Drill Guide Style B 18mm
• 00819034027842: Drill Guide Style B 15mm
• 00819034027835: Drill Guide Style A 15mm
• 00819034027828: Drill Guide Style A 13mm
• 00819034027811: Drill Guide Style A 11mm
• 00819034027804: Sizer Wheel Style B
• 00819034027798: Drill Guide Style A 9mm
• 00819034027781: Sizer Wheel Style A
• 00819034027774: Sizer Wheel Style B
• 00819034027255: Sizer Wheel Style A
• 00819034025398: Tamp Large
• 00819034025381: Tamp Small
• 00819034025213: Superelastic Nitinol Implant System Style B 15 x 12 x 12mm
• 00819034025206: Superelastic Nitinol Implant Style B 15 x 12 x 12mm
• 00819034023776: Tray Based Inserter 25mm
• 00819034023769: Tray Based Inserter 20mm
• 00819034023752: Tray Based Inserter 18mm
• 00819034023745: Tray Based Inserter 15mm
• 00819034023738: Tray Based Inserter 13mm
• 00819034023721: Tray Based Inserter 11mm
• 00819034023714: Tray Based Inserter 9mm
• 00819034023653: Calibrated Drill 15mm Length 2.1mm
• 00819034023639: Targeting Rod Large
• 00819034023622: Targeting Rod Small
• 00819034023615: Calibrated Drill 2.8mm
• 00819034023608: Calibrated Drill 15mm Length 2.1mm
• 00819034023592: Calibrated Drill 2.1mm
• 00819034023585: Superelastic Nitinol Implant System Style B 25 x 20 x 20m
• 00819034023578: Superelastic Nitinol Implant System Style B 20 x 20 x 20mm
• 00819034023561: Superelastic Nitinol Implant System Style B 20 x 15 x 15mm
• 00819034023554: Superelastic Nitinol Implant System Style B 18 x 18 x 15mm
• 00819034023547: Superelastic Nitinol Implant System Style B 18 x 18 x 18mm
• 00819034023530: Superelastic Nitinol Implant System Style B 18 x 15 x 15mm
• 00819034023523: Superelastic Nitinol Implant System Style B 15 x 15 x 15mm
• 00819034023516: Superelastic Nitinol Implant System Style A 15 x 12 x 12mm