PRECICE® Intramedullary Limb Lengthening System P12.5-80V245

GUDID 00887517935595

Retrograde Femur 10°, 12.5mm x 245mm

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Femur nail, sterile

• Primary Device ID: 00887517935595
• NIH Device Record Key: 96893b75-179b-480f-abf2-09b14aa94d7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECICE® Intramedullary Limb Lengthening System
• Version Model Number: P12.5-80V245
• Catalog Number: P12.5-80V245
• Company DUNS: 837845234
• Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com
• Phone: 855-435-5477
• Email: csdepartment@nuvasive.com

Device Dimensions

• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter
• Outer Diameter: 12.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517935595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172628

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-03

On-Brand Devices [PRECICE® Intramedullary Limb Lengthening System]

• 00812258028282: Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur, 10° Bend, 10.7 mm Diameter,
• 00812258028275: Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur, 10° Bend, 8.5 mm Diameter, 1
• 00812258028268: Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur Trochanteric, 10° Bend, 10.7
• 00812258028251: Orthopedic Intramedullary Limb Lengthening Rod, Universal Femur, 8.5 mm Diameter, 150 mm
• 00812258028244: Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur Trochanteric, 10° Bend, 10.7
• 00812258028237: Orthopedic Intramedullary Limb Lengthening Rod, Retrograde Femur Trochanteric, 10° Bend, 8.5 m
• 00812258028220: Orthopedic Intramedullary Limb Lengthening Rod, Antegrade Tibia, 10° Bend, 10.7 mm Diameter, 1
• 00812258028213: Orthopedic Intramedullary Limb Lengthening Rod, Antegrade Tibia, 10° Bend, 8.5 mm Diameter, 15
• 00812258028169: End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm)
• 00812258028152: End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm)
• 00812258028145: End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm)
• 00812258028138: End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm)
• 00812258028121: End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm)
• 00812258026554: Orthopedic surgical instrument (entry drill) - for use with the intramedullary limb lengthening
• 00812258026547: Orthopedic surgical instrument (entry drill) - for use with the intramedullary limb lengthening
• 00812258026288: Orthopedic intramedullary limb lengthening rod, universal femur, 12.5 mm diameter, 190 mm length
• 00812258026271: Orthopedic intramedullary limb lengthening rod, universal femur, 12.5 mm diameter, 170 mm length
• 00812258026264: Orthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 190 mm length
• 00812258026257: Orthopedic intramedullary limb lengthening rod, universal femur, 10.7 mm diameter, 170 mm length
• 00812258026240: Orthopedic intramedullary limb lengthening rod, universal femur, 8.5 mm diameter, 190 mm length
• 00812258026233: Orthopedic intramedullary limb lengthening rod, universal femur, 8.5 mm diameter, 170 mm length
• 00812258026226: Orthopedic intramedullary limb lengthening rod, retrograde femur 10°, 12.5 mm diameter, 190 mm
• 00812258026219: Orthopedic intramedullary limb lengthening rod, retrograde femur 10°, 12.5 mm diameter, 190 mm
• 00812258026202: Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter,
• 00812258026196: Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 10.7 mm diameter,
• 00812258026189: Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 8.5 mm diameter, 1
• 00812258026172: Orthopedic intramedullary limb lengthening rod, antegrade femur trochanteric, 8.5 mm diameter, 1
• 00812258026165: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 12.5 mm diameter, 180 mm length
• 00812258026158: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 12.5 mm diameter, 160 mm length
• 00812258026141: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 180 mm length
• 00812258026134: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 10.7 mm diameter, 160 mm length
• 00812258026127: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 8.5 mm diameter, 180 mm length
• 00812258026110: Orthopedic intramedullary limb lengthening rod, antegrade tibia, 8.5 mm diameter, 160 mm length
• 00812258026103: Orthopedic intramedullary limb lengthening rod, retrograde femur 10°, 12.5 mm diameter, 190 mm
• 00812258026097: Orthopedic intramedullary limb lengthening rod, retrograde femur 10°, 12.5 mm diameter, 170 mm
• 00812258026080: Orthopedic intramedullary limb lengthening rod, retrograde femur 10°, 10.7 mm diameter, 190 mm
• 00812258026073: Orthopedic intramedullary limb lengthening rod, retrograde femur 10°, 10.7 mm diameter, 170 mm
• 00812258026066: Orthopedic intramedullary limb lengthening rod, retrograde femur 10°, 8.5 mm diameter, 190 mm l
• 00812258026059: Orthopedic intramedullary limb lengthening rod, retrograde femur 10° , 8.5 mm diameter, 170 mm
• 00812258026042: Orthopedic intramedullary limb lengthening rod, retrograde femur, 12.5 mm diameter, 365 mm lengt
• 00812258026035: Orthopedic intramedullary limb lengthening rod, retrograde femur, 12.5 mm diameter, 335 mm lengt
• 00812258026028: Orthopedic intramedullary limb lengthening rod, retrograde femur, 12.5 mm diameter, 305 mm lengt
• 00812258026011: Orthopedic intramedullary limb lengthening rod, retrograde femur, 12.5 mm diameter, 275 mm lengt
• 00812258026004: Orthopedic intramedullary limb lengthening rod, retrograde femur, 12.5 mm diameter, 245 mm lengt
• 00812258025991: Orthopedic intramedullary limb lengthening rod, retrograde femur, 12.5 mm diameter, 230 mm lengt
• 00812258025984: Orthopedic intramedullary limb lengthening rod, retrograde femur, 12.5 mm diameter, 215 mm lengt
• 00812258025977: Orthopedic intramedullary limb lengthening rod, retrograde femur, 9.5 mm diameter, 365 mm length
• 00812258025960: Orthopedic intramedullary limb lengthening rod, retrograde femur, 9.5 mm diameter, 335 mm length
• 00812258025953: Orthopedic intramedullary limb lengthening rod, retrograde femur, 9.5 mm diameter, 305 mm length
• 00812258025946: Orthopedic intramedullary limb lengthening rod, retrograde femur, 9.5 mm diameter, 275 mm length