DynaNail

GUDID M970120003506500

DYNANAIL Headless PA Screw, 5mm x 65mm

Medshape, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: M970120003506500
• NIH Device Record Key: 5c743ae2-783f-47d8-bdf8-1a6b57cc58d2
• Commercial Distribution Discontinuation: 2023-06-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DynaNail
• Version Model Number: 1200-03-5065
• Company DUNS: 601306413
• Company Name: Medshape, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M970120003506500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113828

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-27
• Device Publish Date: 2017-02-13

On-Brand Devices [DynaNail]

• M97012000400000: DYNANAIL Endcap
• M9701200011230: DYNANAIL Ankle Arthrodesis Device, 12mm x 30cm
• M97012000112260: DYNANAIL Ankle Arthrodesis Device, 12mm x 26cm
• M970120001122204: DYNANAIL Ankle Arthrodesis Device, 12mm x 22cm
• M97012000112220: DYNANAIL Ankle Arthrodesis Device, 12mm x 22cm
• M97012000110300: DYNANAIL Ankle Arthrodesis Device, 10mm x 30cm
• M97012000110260: DYNANAIL Ankle Arthrodesis Device, 10mm x 26cm
• M970120001102202: DYNANAIL Ankle Arthrodesis Device, 10mm x 22cm
• M97012000110220: DYNANAIL Ankle Arthrodesis Device, 10mm x 22cm
• M970120003511006: DYNANAIL Headless PA Screw, 5mm x 110mm
• M970120003510509: DYNANAIL Headless PA Screw, 5mm x 105mm
• M970120003510005: DYNANAIL Headless PA Screw, 5mm x 100mm
• M970120003509500: DYNANAIL Headless PA Screw, 5mm x 95mm
• M970120003509000: DYNANAIL Headless PA Screw, 5mm x 90mm
• M970120003508500: DYNANAIL Headless PA Screw, 5mm x 85mm
• M970120003508000: DYNANAIL Headless PA Screw, 5mm x 80mm
• M970120003507500: DYNANAIL Headless PA Screw, 5mm x 75mm
• M970120003507000: DYNANAIL Headless PA Screw, 5mm x 70mm
• M970120003506500: DYNANAIL Headless PA Screw, 5mm x 65mm
• M970120002506009: DYNANAIL Headed Cortical Screw, 5mm x 60mm
• M970120002505500: DYNANAIL Headed Cortical Screw, 5mm x 55mm
• M970120002505008: DYNANAIL Headed Cortical Screw, 5mm x 50mm
• M970120002504500: DYNANAIL Headed Cortical Screw, 5mm x 45mm
• M970120002504007: DYNANAIL Headed Cortical Screw, 5mm x 40mm
• M970120002503500: DYNANAIL Headed Cortical Screw, 5mm x 35mm
• M970120002503006: DYNANAIL Headed Cortical Screw, 5mm x 30mm
• M970120002502500: DYNANAIL Headed Cortical Screw, 5mm x 25mm
• M970120002502005: DYNANAIL Headed Cortical Screw, 5mm x 20mm