INnate Implant EXINN923635

GUDID B487EXINN9236350

INnate is a stainless steel bone screw

Exsomed Corporation

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-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: B487EXINN9236350
• NIH Device Record Key: a6531df5-2bf0-44fe-a2c2-ac806e21dc84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INnate Implant
• Version Model Number: EXINN923635
• Catalog Number: EXINN923635
• Company DUNS: 116722111
• Company Name: Exsomed Corporation
• 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 Dimensions

• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 3.6 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B487EXINN9236350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183603

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-05
• Device Publish Date: 2021-09-27

On-Brand Devices [INnate Implant]

• B487EXINN9245750: INnate is a stainless steel bone screw
• B487EXINN9245650: INnate is a stainless steel bone screw
• B487EXINN9245550: INnate is a stainless steel bone screw
• B487EXINN9245500: INnate is a stainless steel bone screw
• B487EXINN9245450: INnate is a stainless steel bone screw
• B487EXINN9245350: INnate is a stainless steel bone screw
• B47EXINN9245400: INnate is a stainless steel bone screw
• B487EXINN9236250: INnate is a stainless steel bone screw
• B487EXINN9245300: INnate is a stainless steel bone screw
• B487EXINN9245250: INnate is a stainless steel bone screw
• B487EXINN9236550: INnate is a stainless steel bone screw
• B487EXINN9236500: INnate is a stainless steel bone screw
• B487EXINN9236450: INnate is a stainless steel bone screw
• B487EXINN9236400: INnate is a stainless steel bone screw
• B487EXINN9236350: INnate is a stainless steel bone screw
• B487EXINN9236300: INnate is a stainless steel bone screw