FRAGMENT FIXATION SYSTEM W10005

GUDID 18053504366423

Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

ORTHOFIX SRL

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 18053504366423
• NIH Device Record Key: e63bc14a-f568-4ce2-89dd-60bc67ce8880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRAGMENT FIXATION SYSTEM
• Version Model Number: 1
• Catalog Number: W10005
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053504366423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944092

FDA Product Code

• JEC: Component, Traction, Invasive

Sterilization

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

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

[18053504366423]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-29
• Device Publish Date: 2019-04-19

On-Brand Devices [FRAGMENT FIXATION SYSTEM]

• 18033509858291: 2,5 MM THREADED WIRES (PACK OF 2)
• 18033509852619: FFS LARGE IMPLANTS L 120/55 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852602: FFS LARGE IMPLANTS L 120/50 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852596: FFS LARGE IMPLANTS L 120/45 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852589: FFS LARGE IMPLANTS L 120/40 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852572: FFS LARGE IMPLANTS L 120/35 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852565: FFS LARGE IMPLANTS L 120/30 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852558: FFS LARGE IMPLANTS L 120/25 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852541: FFS LARGE IMPLANTS L 120/20 MM STERILE THREAD D 2.2 MM (PACK OF 4)
• 18033509852534: FFS LARGE WASHERS (PK OF 4) STERILE
• 18033509852527: FFS MEDIUM IMPLANTS L 120/45MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852510: FFS MEDIUM IMPLANTS L 120/40MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852503: FFS MEDIUM IMPLANTS L 120/35MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852497: FFS MEDIUM IMPLANTS L 120/30MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852480: FFS MEDIUM IMPLANTS L 120/25MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852473: FFS MEDIUM IMPLANTS L 120/23MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852466: FFS MEDIUM IMPLANTS L 120/21MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852459: FFS MEDIUM IMPLANTS L 120/19MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852442: FFS MEDIUM IMPLANTS L 120/17MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852435: FFS MEDIUM IMPLANTS L 120/15MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852428: FFS MEDIUM IMPLANTS L 120/13MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852411: FFS MEDIUM IMPLANTS L 120/11MM STERILE THREAD D 1.6 MM (PACK OF 4)
• 18033509852404: FFS MEDIUM WASHERS (PK OF 4) STERILE
• 18033509852398: FFS SMALL IMPLANTS L 120/21 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18033509852381: FFS SMALL IMPLANTS L 120/19 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18033509852374: FFS SMALL IMPLANTS L 120/17 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18033509852367: FFS SMALL IMPLANTS L 120/15 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18033509852350: FFS SMALL IMPLANTS L 120/13 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18033509852343: FFS SMALL IMPLANTS L 120/11 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18033509852336: FFS SMALL IMPLANTS L 120/9 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18033509852329: FFS SMALL IMPLANTS L 120/7 MM STERILE THREAD D 1.2 MM (PACK OF 4)
• 18032568866605: CEPHALIC BONE SCREW END CAP
• 18032568866407: OSTEOTITE CEPHALIC BONE SCREW 120/30 MM STERILE
• 18032568866391: OSTEOTITE CEPHALIC BONE SCREW 110/30 MM STERILE
• 18032568866360: CANNULATED CEPHALIC BONE SCREW 120/30 MM
• 18032568866353: CANNULATED CEPHALIC BONE SCREW 110/25 MM
• 18032568865615: FFS LARGE IMPLANTS L 120/55 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865608: FFS LARGE IMPLANTS L 120/50 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865592: FFS LARGE IMPLANTS L 120/45 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865585: FFS LARGE IMPLANTS L 120/40 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865578: FFS LARGE IMPLANTS L 120/35 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865561: FFS LARGE IMPLANTS L 120/30 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865554: FFS LARGE IMPLANTS L 120/25 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865547: FFS LARGE IMPLANTS L 120/20 MM THREAD D 2.2 MM (PACK OF 4)
• 18032568865530: FFS LARGE IMPLANTS STERI BOX EMPTY
• 18032568865523: FFS LARGE WASHERS (PK OF 4)
• 18032568865516: FFS MEDIUM IMPLANTS L 120/45MM THREAD D 1.6 MM (PACK OF 4)
• 18032568865509: FFS MEDIUM IMPLANTS L 120/40MM THREAD D 1.6 MM (PACK OF 4)
• 18032568865493: FFS MEDIUM IMPLANTS L 120/35MM THREAD D 1.6 MM (PACK OF 4)
• 18032568865486: FFS MEDIUM IMPLANTS L 120/30MM THREAD D 1.6 MM (PACK OF 4)