DYNAMIC AXIAL FIXATOR 13115

GUDID 18032568033014

TEMPLATE LOCKING SCREW

ORTHOFIX SRL

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 18032568033014
• NIH Device Record Key: 8e0bd8ef-29a1-4e9c-bf25-b1ce36366b6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNAMIC AXIAL FIXATOR
• Version Model Number: 1
• Catalog Number: 13115
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032568033014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955848

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

[18032568033014]

Moist Heat or Steam Sterilization

[18032568033014]

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: 2018-04-18

On-Brand Devices [DYNAMIC AXIAL FIXATOR]

• 18054242511823: CANNULATED DRILL BIT KIT L 250 MM D 4.8 MM 2.2 MM HOLE
• 18054242511557: CALIBRATED DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT
• 18054242510901: DRILL BIT D.3,2 MM L.140 MM TIN COATED - QUICK CONNECT
• 18054242510871: DRILL BIT D.2,9 MM L.140 MM TIN COATED - QUICK CONNECT
• 18033509856099: DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT
• 18033509856082: DRILL BIT D.1,6 MM L.90 MM TIN COATED - QUICK CONNECT
• 18033509856075: DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT
• 18033509856068: DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT
• 18033509856013: CANNULATED DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT STERILE
• 18033509856006: CANNULATED DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT STERILE
• 18032937169672: CALIBRATED DRILL BIT D.4,8 MM L.190 MM TIN COATED - QUICK CONNECT
• 18032937169665: CANNULATED DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT
• 18032568868616: TEMPLATE FOR HEMI-CALLOTASIS DEVICE
• 18032568867671: CALIBRATED DRILL BIT D. 4.8 MM L.280 MM
• 18032568867664: CALIBRATED DRILL BIT D. 4.8 MM L.180 MM
• 18032568866575: KIT MANIGLIONE ORIENTABILE
• 18032568866223: ALIGNMENT GRID
• 18032568864373: D.A.F. CENTRAL BODY
• 18032568864366: D.A.F. SHORT CLAMP
• 18032568864359: D.A.F. LONG CLAMP
• 18032568039610: CANNULATED DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT
• 18032568039603: DRILL BIT D.4,8 MM L.180 MM TIN COATED - QUICK CONNECT
• 18032568035421: OF-GARCHES STANDARD T-CLAMP
• 18032568035360: OF-GARCHES STANDARD LIMB LENGTHENER KIT
• 18032568035292: LONG COMPR/DISTR. UNIT FOR OF-GARCHES EXT. TO 10 CM
• 18032568035285: STANDARD COMPR/DISTR. UNIT FOR OF-GARCHES EXT. TO 5.5 CM
• 18032568033014: TEMPLATE LOCKING SCREW
• 18032568032918: DRILL BIT STOP UNIT D 2.9 MM
• 18032568032901: DRILL BIT DIAMETER 3.2 MM LENGTH 140 MM
• 18032568032895: DRILL BIT KIT DIAMETER 3.2 MM LENGTH 140 MM
• 18032568032871: DRILL BIT KIT DIAMETER 2.9 MM LENGTH 140 MM
• 18032568032772: INSTRUMENTATION STERI BOX EMPTY
• 18032568032765: LOWER EXTREMITY TRAUMA STERI BOX EMPTY
• 18032568032734: TRAUMA STERI BOX EMPTY
• 18032568032574: MANIPULATION FORCEPS SELF LOCKING (DAF & PROCALLUS)
• 18032568032529: RULAND PILOT WIRE GUIDE DIAMETER 2 MM LENGTH 115 MM
• 18032568032512: RULAND PILOT WIRE GUIDE DIAMETER 2 MM LENGTH 75 MM
• 18032568032499: TRAUMA-GARCHES CLAMP TEMPLATE
• 18032568032482: PELVIC SCREW GUIDE LENGTH 100 MM
• 18032568032444: SELF-ALIGNING TEMPLATE FOR ARTIC. BODY FOR THE HIP
• 18032568032437: TEMPLATE ALIGNMENT SUPPORT FOR OF-GARCHES
• 18032568032413: TEMPLATE LOCKING SCREW FOR OF-GARCHES
• 18032568032390: OF-GARCHES ASSEMBLY TEMPLATE
• 18032568032338: SCREW GUIDE LENGTH 45 MM
• 18032568032314: DAF SHORT BODY TEMPLATE
• 18032568032284: HAMMER LOCKING NUT
• 18032568032277: DRILL GUIDE DIAMETER 3.2 MM LENGTH 80 MM
• 18032568032239: HAMMER INTERCHANGEABLE HEAD
• 18032568032222: HAMMER
• 18032568032215: TEMPLATE LOCKING SCREW