ArcPhix System EXARC903028

GUDID B487EXARC9030280

ArcPhix Compression Screw System The system includes the implant, two guide wires, one cannulated drill, and a driver.

EXSOMED CORPORATION

Orthopaedic implant driver

• Primary Device ID: B487EXARC9030280
• NIH Device Record Key: db66b1c1-8bb7-4a1e-9edc-5fb934cd2632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArcPhix System
• Version Model Number: EXARC903028
• Catalog Number: EXARC903028
• 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: true
• 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

• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B487EXARC9030280 [Primary]

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: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-04-06

Devices Manufactured by EXSOMED CORPORATION

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• B487EXINN9215070 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215080 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215090 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215100 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215110 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215120 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.
• B487EXINN9215130 - NanoPhix Implant: 2024-02-01 NanoPhix is a stainless steel bone screw.