SOLE MEDIAL COLUMN FUSION PLATE 84010L

GUDID 18053340347716

SOLE MCF SS PLATE STANDARD LARGE LEFT

ORTHOFIX SRL

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 18053340347716
• NIH Device Record Key: d556999c-9d9c-4618-ab6a-1dad9edd086b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLE MEDIAL COLUMN FUSION PLATE
• Version Model Number: 1
• Catalog Number: 84010L
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: true
• 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
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Dimensions

• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter
• Height: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053340347716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210157

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

[18053340347716]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-11
• Device Publish Date: 2021-06-03

On-Brand Devices [SOLE MEDIAL COLUMN FUSION PLATE]

• 18053340348652: SOLE MCF TRAY COMPLETE EMPTY
• 18053340348522: SS NON-LOCKING SCREW L60MM D4MM
• 18053340348515: SS NON-LOCKING SCREW L55MM D4MM
• 18053340348508: SS NON-LOCKING SCREW L50MM D4MM
• 18053340348492: SS NON-LOCKING SCREW L46MM D4MM
• 18053340348485: SS NON-LOCKING SCREW L42MM D4MM
• 18053340348478: SS NON-LOCKING SCREW L38MM D4MM
• 18053340348461: SS NON-LOCKING SCREW L34MM D4MM
• 18053340348454: SS NON-LOCKING SCREW L30MM D4MM
• 18053340348447: SS NON-LOCKING SCREW L28MM D4MM
• 18053340348430: SS NON-LOCKING SCREW L26MM D4MM
• 18053340348423: SS NON-LOCKING SCREW L24MM D4MM
• 18053340348416: SS NON-LOCKING SCREW L22MM D4MM
• 18053340348409: SS NON-LOCKING SCREW L20MM D4MM
• 18053340348393: SS NON-LOCKING SCREW L18MM D4MM
• 18053340348386: SS NON-LOCKING SCREW L16MM D4MM
• 18053340348379: SS NON-LOCKING SCREW L14MM D4MM
• 18053340348362: SS NON-LOCKING SCREW L12MM D4MM
• 18053340348355: SS NON-LOCKING SCREW L10MM D4MM
• 18053340348348: SS NON-LOCKING SCREW L60MM D5MM
• 18053340348331: SS NON-LOCKING SCREW L55MM D5MM
• 18053340348324: SS NON-LOCKING SCREW L50MM D5MM
• 18053340348317: SS NON-LOCKING SCREW L46MM D5MM
• 18053340348300: SS NON-LOCKING SCREW L42MM D5MM
• 18053340348294: SS NON-LOCKING SCREW L38MM D5MM
• 18053340348287: SS NON-LOCKING SCREW L34MM D5MM
• 18053340348270: SS NON-LOCKING SCREW L30MM D5MM
• 18053340348263: SS NON-LOCKING SCREW L28MM D5MM
• 18053340348256: SS NON-LOCKING SCREW L26MM D5MM
• 18053340348249: SS NON-LOCKING SCREW L24MM D5MM
• 18053340348232: SS NON-LOCKING SCREW L22MM D5MM
• 18053340348225: SS NON-LOCKING SCREW L20MM D5MM
• 18053340348218: SS NON-LOCKING SCREW L18MM D5MM
• 18053340348201: SS NON-LOCKING SCREW L16MM D5MM
• 18053340348195: SS NON-LOCKING SCREW L14MM D5MM
• 18053340348188: SS NON-LOCKING SCREW L12MM D5MM
• 18053340348171: SS NON-LOCKING SCREW L10MM D5MM
• 18053340348164: SS VA LOCKING SCREW L60MM D4MM
• 18053340348157: SS VA LOCKING SCREW L55MM D4MM
• 18053340348140: SS VA LOCKING SCREW L50MM D4MM
• 18053340348133: SS VA LOCKING SCREW L46MM D4MM
• 18053340348126: SS VA LOCKING SCREW L42MM D4MM
• 18053340348119: SS VA LOCKING SCREW L38MM D4MM
• 18053340348102: SS VA LOCKING SCREW L34MM D4MM
• 18053340348096: SS VA LOCKING SCREW L30MM D4MM
• 18053340348089: SS VA LOCKING SCREW L28MM D4MM
• 18053340348072: SS VA LOCKING SCREW L26MM D4MM
• 18053340348065: SS VA LOCKING SCREW L24MM D4MM
• 18053340348058: SS VA LOCKING SCREW L22MM D4MM
• 18053340348041: SS VA LOCKING SCREW L20MM D4MM