InCore Subtalar

GUDID 00817701029007

InCore Subtalar 5.5mm x 82mm Screw

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

• Primary Device ID: 00817701029007
• NIH Device Record Key: 273c6c4a-178c-432c-bfae-8d2d7890846d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InCore Subtalar
• Version Model Number: ICSUB55082
• Company DUNS: 192756786
• Company Name: Medartis Inc.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817701029007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213301

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2023-09-29
• Device Publish Date: 2023-01-31

On-Brand Devices [InCore Subtalar]

• 00817701029250: InCore Subtalar Implant Bushing, Large
• 00817701029243: InCore Subtalar Implant Bushing, Medium
• 00817701029236: InCore Subtalar Implant Bushing, Small
• 00817701029229: InCore Subtalar Drill Bushing, Large
• 00817701028833: InCore Subtalar Replacement Compression Screw
• 00817701028826: InCore Subtalar Replacement Compression Frame Left
• 00817701028819: InCore Subtalar Replacement Compression Frame Right
• 00817701028802: InCore Subtalar 5.6mm Drill Bit Disposable
• 00817701028796: InCore Subtalar T25 Driver Disposable
• 00817701028789: InCore Subtalar 8.0mm Post Drill Disposable
• 00817701028772: InCore Subtalar Instrument Case Lid
• 00817701028765: InCore Subtalar Instrument Case
• 00817701028741: InCore Subtalar Depth Probe
• 00817701028734: InCore Subtalar Removal Fastener
• 00817701028727: InCore Subtalar Removal Slap Hammer
• 00817701028710: InCore Subtalar Removal Drill Guide
• 00817701028703: InCore Subtalar 5.6mm Drill Bit
• 00817701028697: InCore Subtalar T25 Driver
• 00817701028680: InCore Subtalar 8.0mm Post Drill
• 00817701028673: InCore Subtalar Post Fastener
• 00817701028666: InCore Subtalar Drill Bushing, Medium
• 00817701028659: InCore Subtalar Drill Bushing, Small
• 00817701028642: InCore Subtalar Targeting Guide Assembly Left
• 00817701028635: InCore Subtalar Targeting Guide Assembly Right
• 00817701028628: InCore Subtalar Post Guide Left
• 00817701028611: InCore Subtalar Post Guide Right
• 00817701029298: InCore Subtalar K-Wires, Sterile
• 00817701029144: InCore Subtalar 5.5mm x 110mm Screw
• 00817701029137: InCore Subtalar 5.5mm x 108mm Screw
• 00817701029120: InCore Subtalar 5.5mm x 106mm Screw
• 00817701029113: InCore Subtalar 5.5mm x 104mm Screw
• 00817701029106: InCore Subtalar 5.5mm x 102mm Screw
• 00817701029090: InCore Subtalar 5.5mm x 100mm Screw
• 00817701029083: InCore Subtalar 5.5mm x 98mm Screw
• 00817701029076: InCore Subtalar 5.5mm x 96mm Screw
• 00817701029069: InCore Subtalar 5.5mm x 94mm Screw
• 00817701029052: InCore Subtalar 5.5mm x 92mm Screw
• 00817701029045: InCore Subtalar 5.5mm x 90mm Screw
• 00817701029038: InCore Subtalar 5.5mm x 88mm Screw
• 00817701029021: InCore Subtalar 5.5mm x 86mm Screw
• 00817701029014: InCore Subtalar 5.5mm x 84mm Screw
• 00817701029007: InCore Subtalar 5.5mm x 82mm Screw
• 00817701028994: InCore Subtalar 5.5mm x 80mm Screw
• 00817701028987: InCore Subtalar 5.5mm x 78mm Screw
• 00817701028970: InCore Subtalar 5.5mm x 76mm Screw
• 00817701028963: InCore Subtalar 5.5mm x 74mm Screw
• 00817701028956: InCore Subtalar 5.5mm x 72mm Screw
• 00817701028949: InCore Subtalar 5.5mm x 70mm Screw
• 00817701028932: InCore Subtalar 5.5mm x 68mm Screw
• 00817701028925: InCore Subtalar 5.5mm x 66mm Screw