Escalade Acetabular System

GUDID 00822409017140

46mm Shell Multi-Hole

Ortho Development Corporation

Acetabular shell

• Primary Device ID: 00822409017140
• NIH Device Record Key: f41843ca-b87f-4bab-ae72-d56096757e6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Escalade Acetabular System
• Version Model Number: 170-0346
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter
• Outer Diameter: 46 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409017140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103384

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

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: 2015-08-31

On-Brand Devices [Escalade Acetabular System]

• 00822409030040: Low Profile Cancellous Screw 65mm
• 00822409030033: Low Profile Cancellous Screw 60mm
• 00822409030026: Low Profile Cancellous Screw 55mm
• 00822409030019: Low Profile Cancellous Screw 50mm
• 00822409030002: Low Profile Cancellous Screw 45mm
• 00822409029990: Low Profile Cancellous Screw 40mm
• 00822409029983: Low Profile Cancellous Screw 35mm
• 00822409029976: Low Profile Cancellous Screw 30mm
• 00822409029969: Low Profile Cancellous Screw 25mm
• 00822409029952: Low Profile Cancellous Screw 20mm
• 00822409029945: Low Profile Cancellous Screw 15mm
• 00822409018178: 40x64-70 +0 Hooded Liner HXLPE
• 00822409018161: 40x62 +0 Hooded Liner HXLPE
• 00822409018154: 40x60 +0 Hooded Liner HXLPE
• 00822409018147: 40x58 +1 Hooded Liner HXLPE
• 00822409018130: 40x56 +3 Hooded Liner HXLPE
• 00822409018123: 36x64-70 +0 Hooded Liner HXLPE
• 00822409018116: 36x62 +0 Hooded Liner HXLPE
• 00822409018109: 36x60 +0 Hooded Liner HXLPE
• 00822409018093: 36x58 +0 Hooded Liner HXLPE
• 00822409018086: 36x56 +0 Hooded Liner HXLPE
• 00822409018079: 36x54 +1 Hooded Liner HXLPE
• 00822409018062: 36x52 +3 Hooded Liner HXLPE
• 00822409018055: 32x64-70 +0 Hooded Liner HXLPE
• 00822409018048: 32x62 +0 Hooded Liner HXLPE
• 00822409018031: 32x60 +0 Hooded Liner HXLPE
• 00822409018024: 32x58 +0 Hooded Liner HXLPE
• 00822409018017: 32x56 +0 Hooded Liner HXLPE
• 00822409018000: 32x54 +0 Hooded Liner HXLPE
• 00822409017997: 32x52 +0 Hooded Liner HXLPE
• 00822409017980: 32x50 +1 Hooded Liner HXLPE
• 00822409017973: 32x48 +3 Hooded Liner HXLPE
• 00822409017966: 28x64-70 +0 Hooded Liner HXLPE
• 00822409017959: 28x62 +0 Hooded Liner HXLPE
• 00822409017942: 28x60 +0 Hooded Liner HXLPE
• 00822409017935: 28x58 +0 Hooded Liner HXLPE
• 00822409017928: 28x56 +0 Hooded Liner HXLPE
• 00822409017911: 28x54 +0 Hooded Liner HXLPE
• 00822409017904: 28x52 +0 Hooded Liner HXLPE
• 00822409017898: 28x50 +0 Hooded Liner HXLPE
• 00822409017881: 28x46 +1 Hooded Liner HXLPE
• 00822409017874: 28x44 +3 Hooded Liner HXLPE
• 00822409017867: 26x44 +1 Hooded Liner HXLPE
• 00822409017850: 26x42 +3 Hooded Liner HXLPE
• 00822409017843: 22x40 +0 Hooded Liner HXLPE
• 00822409017836: 40x64-70mm +0 Neutral Liner HXLPE
• 00822409017829: 40x62mm +0 Neutral Liner HXLPE
• 00822409017812: 40x60mm +0 Neutral Liner HXLPE
• 00822409017805: 40x58mm +1 Neutral Liner HXLPE
• 00822409017799: 40x56mm +3 Neutral Liner HXLPE