CONTOURS LAPIDUS PLATING SYSTEM PSC35D35

GUDID 18054242513865

SCREW, LAPIDUS, 3.5MM X 1.25 X 35MM W/2.5MM HEX, BONE

ORTHOFIX SRL

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

• Primary Device ID: 18054242513865
• NIH Device Record Key: f0cc02fa-1391-44ad-b7b0-f4bc979b428a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOURS LAPIDUS PLATING SYSTEM
• Version Model Number: 1
• Catalog Number: PSC35D35
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: false
• 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: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Dimensions

• Width: 234 Millimeter
• Width: 234 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242513865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102201

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[18054242513865]

Moist Heat or Steam Sterilization

[18054242513865]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-01

On-Brand Devices [CONTOURS LAPIDUS PLATING SYSTEM]

• 18054242515210: EMPTY INSTRUMENT TRAY,CONTOURS LPS
• 18054242514251: TAP SLEEVE FOR 2.5MM AND 3.5MM DRILL BITS
• 18054242514244: 2.7-4.0MM COUNTERSINK W/2MM TIP, AO
• 18054242514237: SMALL PLATE BENDING IRON 5.5
• 18054242514183: SCREW, LAPIDUS, 3.5MM X 1.25 X 32MM W/4.5MM X .75 LOCKING
• 18054242514176: SCREW, LAPIDUS, 3.5MM X 1.25 X 30MM W/4.5MM X .75 LOCKING
• 18054242514169: SCREW, LAPIDUS, 3.5MM X 1.25 X 12MM W/4.5MM X .75 LOCKING
• 18054242514152: SCREW, LAPIDUS, 3.5MM X 1.25 X 28MM W/4.5MM X 7.5 LOCKING
• 18054242514145: SCREW, LAPIDUS, 3.5MM X 1.25 X 26MM W/4.5MM X .75 LOCKING
• 18054242514138: SCREW, LAPIDUS, 3.5MM X 1.25 X 24MM W/4.5MM X .75 LOCKING
• 18054242514121: SCREW, LAPIDUS, 3.5MM X 1.25 X 22MM W/4.5MM X .75 LOCKING
• 18054242514114: SCREW, LAPIDUS, 3.5MM X 1.25 X 20MM W/4.5MM X .75 LOCKING
• 18054242514107: SCREW, LAPIDUS, 3.5MM X 1.25 X 18MM W/4.5MM X .75 LOCKING
• 18054242514091: SCREW, LAPIDUS, 3.5MM X 1.25 X 16MM W/4.5MM X .75 LOCKING
• 18054242514084: SCREW, LAPIDUS, 3.5MM X 1.25 X 14MM W/4.5MM X .75 LOCKING
• 18054242514077: SCREW, LAPIDUS, 3.5MM X 1.25 X 32MM NON-LOCKING
• 18054242514060: SCREW, LAPIDUS, 3.5MM X 1.25 X 30MM NON-LOCKING
• 18054242514053: SCREW, LAPIDUS, 3.5MM X 1.25 X 12MM NON-LOCKING
• 18054242514046: SCREW, LAPIDUS, 3.5MM X 1.25 X 28MM NON-LOCKING
• 18054242514039: SCREW, LAPIDUS, 3.5MM X 1.25 X 24MM NON-LOCKING
• 18054242514022: SCREW, LAPIDUS, 3.5MM X 1.25 X 22MM NON-LOCKING
• 18054242514015: SCREW, LAPIDUS, 3.5MM X 1.25 X 20MM NON-LOCKING
• 18054242514008: SCREW, LAPIDUS, 3.5MM X 1.25 X 18MM NON-LOCKING
• 18054242513995: SCREW, LAPIDUS, 3.5MM X 1.25 X 16MM NON-LOCKING
• 18054242513988: SCREW, LAPIDUS, 3.5MM X 1.25 X 14MM NON-LOCKING
• 18054242513971: SCREW, LAPIDUS, 3.5MM X 1.25 X 22MM W/2.5MM HEX, BONE
• 18054242513964: SCREW, LAPIDUS, 3.5MM X 1.25 X 48MM W/2.5MM HEX, BONE
• 18054242513957: SCREW, LAPIDUS, 3.5MM X 1.25 X 46MM W/2.5MM HEX, BONE
• 18054242513940: SCREW, LAPIDUS, 3.5MM X 1.25 X 44MM W/2.5MM HEX, BONE
• 18054242513933: SCREW, LAPIDUS, 3.5MM X 1.25 X 42MM W/2.5MM HEX, BONE
• 18054242513926: SCREW, 3.5MM X 1.25 X 14MM W/2.5MM HEX, BONE
• 18054242513919: SCREW, 3.5MM X 1.25 X 12MM W/2.5MM HEX, BONE
• 18054242513902: SCREW, 3.5MM X 1.25 X 10MM W/2.5MM HEX, BONE
• 18054242513896: SCREW, LAPIDUS, 3.5MM X 1.25 X 50MM W/2.5MM HEX, BONE
• 18054242513872: SCREW, LAPIDUS, 3.5MM X 1.25 X 40MM W/2.5MM HEX, BONE
• 18054242513865: SCREW, LAPIDUS, 3.5MM X 1.25 X 35MM W/2.5MM HEX, BONE
• 18054242513858: SCREW, LAPIDUS, 3.5MM X 1.25 X 30MM W/2.5MM HEX, BONE
• 18054242513841: SCREW, LAPIDUS, 3.5MM X 1.25 X 25MM W/2.5MM HEX, BONE
• 18054242513834: SCREW, LAPIDUS, 3.5MM X 1.25 X 20MM W/2.5MM HEX, BONE
• 18054242513827: SCREW, 3.5MM X 1.25 X 18MM W/2.5MM HEX, BONE
• 18054242513810: SCREW, 3.5MM X 1.25 X 16MM W/2.5MM HEX, BONE
• 18054242513797: PLATE, LAPIDUS, RIGHT
• 18054242513780: PLATE, LAPIDUS, LEFT
• 18054242513759: SCREW, LAPIDUS, 3.5MM X 1.25 X 26MM NON-LOCKING
• 18054242513742: 2.5 MM CANNULATED DRILL BIT, LAPIDUS SYSTEM
• 18054242513735: 2.5 MM QUICK READ DRILL BIT, LAPIDUS SYSTEM