Escalade Acetabular System

GUDID 00822409017386

Dia.6.5x15mm Cancellous Bone Screw Low Profile

Ortho Development Corporation

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00822409017386
NIH Device Record Key29a2806b-20ce-4f79-8ac2-874cc9783a8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEscalade Acetabular System
Version Model Number170-2015
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com
Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter
Outer Diameter6.5 Millimeter
Length15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409017386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-26
Device Publish Date2015-08-31

On-Brand Devices [Escalade Acetabular System]

00822409030040Low Profile Cancellous Screw 65mm
00822409030033Low Profile Cancellous Screw 60mm
00822409030026Low Profile Cancellous Screw 55mm
00822409030019Low Profile Cancellous Screw 50mm
00822409030002Low Profile Cancellous Screw 45mm
00822409029990Low Profile Cancellous Screw 40mm
00822409029983Low Profile Cancellous Screw 35mm
00822409029976Low Profile Cancellous Screw 30mm
00822409029969Low Profile Cancellous Screw 25mm
00822409029952Low Profile Cancellous Screw 20mm
00822409029945Low Profile Cancellous Screw 15mm
0082240901817840x64-70 +0 Hooded Liner HXLPE
0082240901816140x62 +0 Hooded Liner HXLPE
0082240901815440x60 +0 Hooded Liner HXLPE
0082240901814740x58 +1 Hooded Liner HXLPE
0082240901813040x56 +3 Hooded Liner HXLPE
0082240901812336x64-70 +0 Hooded Liner HXLPE
0082240901811636x62 +0 Hooded Liner HXLPE
0082240901810936x60 +0 Hooded Liner HXLPE
0082240901809336x58 +0 Hooded Liner HXLPE
0082240901808636x56 +0 Hooded Liner HXLPE
0082240901807936x54 +1 Hooded Liner HXLPE
0082240901806236x52 +3 Hooded Liner HXLPE
0082240901805532x64-70 +0 Hooded Liner HXLPE
0082240901804832x62 +0 Hooded Liner HXLPE
0082240901803132x60 +0 Hooded Liner HXLPE
0082240901802432x58 +0 Hooded Liner HXLPE
0082240901801732x56 +0 Hooded Liner HXLPE
0082240901800032x54 +0 Hooded Liner HXLPE
0082240901799732x52 +0 Hooded Liner HXLPE
0082240901798032x50 +1 Hooded Liner HXLPE
0082240901797332x48 +3 Hooded Liner HXLPE
0082240901796628x64-70 +0 Hooded Liner HXLPE
0082240901795928x62 +0 Hooded Liner HXLPE
0082240901794228x60 +0 Hooded Liner HXLPE
0082240901793528x58 +0 Hooded Liner HXLPE
0082240901792828x56 +0 Hooded Liner HXLPE
0082240901791128x54 +0 Hooded Liner HXLPE
0082240901790428x52 +0 Hooded Liner HXLPE
0082240901789828x50 +0 Hooded Liner HXLPE
0082240901788128x46 +1 Hooded Liner HXLPE
0082240901787428x44 +3 Hooded Liner HXLPE
0082240901786726x44 +1 Hooded Liner HXLPE
0082240901785026x42 +3 Hooded Liner HXLPE
0082240901784322x40 +0 Hooded Liner HXLPE
0082240901783640x64-70mm +0 Neutral Liner HXLPE
0082240901782940x62mm +0 Neutral Liner HXLPE
0082240901781240x60mm +0 Neutral Liner HXLPE
0082240901780540x58mm +1 Neutral Liner HXLPE
0082240901779940x56mm +3 Neutral Liner HXLPE
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