N-Force 4.0 Fixation System IN043-1

GUDID 00815612020236

N-Force 4.0 Fixation System Inset Washer

Innovision, Inc

Orthopaedic bone washer, sterile

• Primary Device ID: 00815612020236
• NIH Device Record Key: 56e5413b-52a2-4303-b6d1-663197e55cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N-Force 4.0 Fixation System
• Version Model Number: IN043-1
• Catalog Number: IN043-1
• Company DUNS: 942243767
• Company Name: Innovision, 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: 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

Customer Support Contacts

• Phone: 1(800)348-2759
• Email: contactus@zimmberbiomet.com
• Phone: 1(800)348-2759
• Email: contactus@zimmberbiomet.com
• Phone: 1(800)348-2759
• Email: contactus@zimmberbiomet.com
• Phone: 1(800)348-2759
• Email: contactus@zimmberbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815612020236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132244

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-05

On-Brand Devices [N-Force 4.0 Fixation System]

• 00815612020236: N-Force 4.0 Fixation System Inset Washer
• 00815612020229: N-Force 4.0 Fixation System Sheath & Sheath Adapter Assembly
• 00815612020212: N-Force 4.0 Fixation System 25mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020205: N-Force 4.0 Fixation System 30mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020199: N-Force 4.0 Fixation System 35mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020182: N-Force 4.0 Fixation System 40mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020175: N-Force 4.0 Fixation System 45mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020168: N-Force 4.0 Fixation System 50mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020151: N-Force 4.0 Fixation System 55mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020144: N-Force 4.0 Fixation System 60mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020137: N-Force 4.0 Fixation System 65mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020120: N-Force 4.0 Fixation System 70mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020113: N-Force 4.0 Fixation System 75mm Fully Cannulated (FC) Screw, Sheath & Adapter Assembly
• 00815612020106: N-Force 4.0 Fixation System 75mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020090: N-Force 4.0 Fixation System 70mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020083: N-Force 4.0 Fixation System 65mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020076: N-Force 4.0 Fixation System 60mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020069: N-Force 4.0 Fixation System 55mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020052: N-Force 4.0 Fixation System 50mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020045: N-Force 4.0 Fixation System 45mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020038: N-Force 4.0 Fixation System 40mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020021: N-Force 4.0 Fixation System 35mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020014: N-Force 4.0 Fixation System 30mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly
• 00815612020007: N-Force 4.0 Fixation System 25mm Partially Cannulated (PC) Screw, Sheath & Adapter Assembly