TRUELOK EVO 99-88017

GUDID 18052469472262

TRUELOK EVO SET RX FOOTPLATE WITH RING D200MM RX STRUTS LONG STERILE

ORTHOFIX SRL

External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 18052469472262
• NIH Device Record Key: 627f3255-b9fe-46b4-a1fa-af10a5815d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUELOK EVO
• Version Model Number: 1
• Catalog Number: 99-88017
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18052469472262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212044

FDA Product Code

• LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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: 2022-01-05
• Device Publish Date: 2021-12-28

On-Brand Devices [TRUELOK EVO]

• 18052469472361: TRUELOK EVO SPEEDBOLT PACK OF 2 STERILE
• 18052469472354: TRUELOK EVO SPEEDNUT PACK OF 2 STERILE
• 18052469472347: TRUELOK EVO 8MM HALF PIN FIX BOLT PACK OF 4 STERILE
• 18052469472330: TRUELOK EVO HALF PIN FIXATION BOLT PACK OF 4 STERILE
• 18052469472323: TRUELOK EVO BOLT PACK OF 4 L16.5MM STERILE
• 18052469472316: TRUELOK EVO WIRE FIXATION BOLT PACK OF 4 STERILE
• 18052469472309: TRUELOK EVO NUT WITH WASHER PACK OF 5 STERILE
• 18052469472293: TRUELOK EVO CONN ELEMENT K WIRES CYLINDR PINS SET STERILE
• 18052469472286: TRUELOK EVO CONNECTION ELEMENT CONICAL PINS SET STERILE
• 18052469472279: TRUELOK EVO CONNECTION ELEMENT CYLINDR PINS SET STERILE
• 18052469472262: TRUELOK EVO SET RX FOOTPLATE WITH RING D200MM RX STRUTS LONG STERILE
• 18052469472255: TL-HEX SET FOOTPLATE WITH RING D180MM RX STRUTS LONG STERILE
• 18052469472248: TL-HEX SET FOOTPLATE WITH RING D160MM RX STRUTS LONG STERILE
• 18052469472231: TL-HEX SET RINGS D200MM RX STRUTS MEDIUM STERILE
• 18052469472224: TL-HEX SET RINGS D200MM RX STRUTS LONG STERILE
• 18052469472217: TL-HEX SET RINGS D180MM RX STRUTS MEDIUM STERILE
• 18052469472200: TL-HEX SET RINGS D180MM RX STRUTS LONG STERILE
• 18052469472194: TL-HEX SET RINGS D160MM RX STRUTS LONG STERILE
• 18052469472187: TL-HEX SET RINGS D160MM RX STRUTS LONG STERILE
• 18052469472170: TRUELOK EVO SET RX FOOTPLATE WITH RING D180MM RX STRUTS LONG STERILE
• 18052469472163: TRUELOK EVO SET RX FOOTPLATE WITH RING D160MM RX STRUTS LONG STERILE
• 18052469472156: TRUELOK EVO SET RX RINGS D200MM RX STRUTS MEDIUM STERILE
• 18052469472149: TRUELOK EVO SET RX RINGS D200MM RX STRUTS LONG STERILE
• 18052469472132: TRUELOK EVO SET RX RINGS D180MM RX STRUTS MEDIUM STERILE
• 18052469472125: TRUELOK EVO SET RX RINGS D180MM RX STRUTS LONG STERILE
• 18052469472118: TRUELOK EVO SET RX RINGS D160MM RX STRUTS MEDIUM STERILE
• 18052469472101: TRUELOK EVO SET RX RINGS D160MM RX STRUTS LONG STERILE
• 18052469472095: TRUELOK EVO RX STRUT MEDIUM STATIC STERILE
• 18052469472088: TRUELOK EVO RX STRUT MEDIUM WITH DYNA STERILE
• 18052469472071: TRUELOK EVO RX STRUT LONG WITH DYNA STERILE
• 18052469472064: TRUELOK EVO RX FOOT ARCH D200MM STERILE
• 18052469472057: TRUELOK EVO RX FOOT ARCH D180MM STERILE
• 18052469472040: TRUELOK EVO RX FOOT ARCH D160MM STERILE
• 18052469472033: TRUELOK EVO RX FOOT ARCH D140MM STERILE
• 18052469472026: TRUELOK EVO RX FOOTPLATE D200MM STERILE
• 18052469472019: TRUELOK EVO RX FOOTPLATE D180MM STERILE
• 18052469472002: TRUELOK EVO RX FOOTPLATE D160MM STERILE
• 18052469471999: TRUELOK EVO RX FOOTPLATE D140MM STERILE
• 18052469471982: TRUELOK EVO RX FULL RING D200MM STERILE
• 18052469471975: TRUELOK EVO RX FULL RING D180MM STERILE
• 18052469471968: TRUELOK EVO RX FULL RING D160MM STERILE
• 18052469471951: TRUELOK EVO RX FULL RING D140MM STERILE
• 18052469471944: TRUELOK EVO RX 3/8 MODULAR RING D200MM STERILE
• 18052469471937: TRUELOK EVO RX 3/8 MODULAR RING D180MM STERILE
• 18052469471920: TRUELOK EVO RX 3/8 MODULAR RING D160MM STERILE
• 18052469471913: TRUELOK EVO RX 3/8 MODULAR RING D140MM STERILE
• 18052469471906: TRUELOK EVO RX 5/8 MODULAR RING D200MM STERILE
• 18052469471890: TRUELOK EVO RX 5/8 MODULAR RING D180MM STERILE
• 18052469471883: TRUELOK EVO RX 5/8 MODULAR RING D160MM STERILE
• 18052469471876: TRUELOK EVO RX 5/8 MODULAR RING D140MM STERILE