PRECICE® Intramedullary Limb Lengthening System EAD-P2-013

GUDID 00812258022907

ERC 2P Shipping Package EU

NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Distraction plate/rod controller Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control Distraction plate/rod adjustment remote control
Primary Device ID00812258022907
NIH Device Record Key769e8924-13fb-4e36-8853-ccd58a5a2881
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRECICE® Intramedullary Limb Lengthening System
Version Model NumberEAD-P2-013
Catalog NumberEAD-P2-013
Company DUNS837845234
Company NameNUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com
Phone855-435-5477
Emailcsdepartment@nuvasive.com

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100812258022907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

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

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

Trademark Results [PRECICE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRECICE
PRECICE
97287304 not registered Live/Pending
PRECICE MOTORSPORTS LLC
2022-02-28
PRECICE
PRECICE
88073801 not registered Live/Pending
Epic Ice, LLC
2018-08-10
PRECICE
PRECICE
85064864 4158334 Live/Registered
NUVASIVE, INC.
2010-06-16
PRECICE
PRECICE
76250632 not registered Dead/Abandoned
KLA-Tencor Corporation
2001-05-03
PRECICE
PRECICE
75092861 not registered Dead/Abandoned
Cadence Design Systems, Inc.
1996-04-23
PRECICE
PRECICE
75072688 not registered Dead/Abandoned
BIODEX MEDICAL SYSTEMS, INC.
1996-03-14

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