NEOFIT P10 ST245

GUDID 03760225712955

NEOFIT MTP PLATE LEFT STERILE SIZE 2 - 45 MM

IN2BONES

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 03760225712955
• NIH Device Record Key: cd1a19b0-324b-48f0-996c-fecd73d71d93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEOFIT
• Version Model Number: P10 ST245
• Catalog Number: P10 ST245
• Company DUNS: 263616749
• Company Name: IN2BONES
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760225712955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160995

FDA Product Code

• HRS: Plate, 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: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [NEOFIT]

• 03760225716144: P01 00381
• 03760225716519: NEOFIT REVERSIBLE DRILL GUIDE OBLONG HOLES
• 03760225716502: NEOFIT DRILL GUIDE WITH MEASURING FUNCTION
• 03760225716168: HOLDER NEOFIT DRILL GUIDE
• 03760225716151: NEOFIT TRIAL PLATE SIZE 35 MM
• 03760225714515: NEOFIT MTP PLATE LEFT STERILE SIZE 0 - 35 MM
• 03760225714508: NEOFIT MTP PLATE RIGHT STERILE SIZE 0 - 35 MM
• 03760225714201: NEOFIT PLATE BENDER RIGHT
• 03760225714195: NEOFIT PLATE BENDER LEFT
• 03760225714188: NEOFIT MODULAR DRILL GUIDE STD DIAM 2.0 MM
• 03760225714171: NEOFIT DRILL GUIDE OBLONG - LEFT
• 03760225714164: NEOFIT DRILL GUIDE OBLONG - RIGHT
• 03760225714157: NEOFIT DRILL GUIDE STD DIAM 2.0 MM
• 03760225714140: NEOFIT TRIAL PLATE SIZE 50 MM
• 03760225714133: NEOFIT TRIAL PLATE SIZE 45 MM
• 03760225714126: NEOFIT TRIAL PLATE SIZE 40 MM
• 03760225714072: NEOFIT CONTAINER
• 03760225713198: NEOFIT BURRS KIT
• 03760225712962: NEOFIT MTP PLATE LEFT STERILE SIZE 3 - 50 MM
• 03760225712955: NEOFIT MTP PLATE LEFT STERILE SIZE 2 - 45 MM
• 03760225712948: NEOFIT MTP PLATE LEFT STERILE SIZE 1 - 40 MM
• 03760225712931: NEOFIT MTP PLATE RIGHT STERILE SIZE 3- 50 MM
• 03760225712924: NEOFIT MTP PLATE RIGHT STERILE SIZE 2- 45 MM
• 03760225712917: NEOFIT MTP PLATE RIGHT STERILE SIZE 1 - 40 MM
• 03701337607227: NEOFIT BASE CONTAINER
• 03701337606077: NEOFIT PLATE INSTRUMENT POSITION