Escalade Acetabular System

GUDID 00822409017256

68mm Shell Multi-Hole

Ortho Development Corporation

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

• Primary Device ID: 00822409017256
• NIH Device Record Key: c06fd8b8-0b16-4bdc-8485-0067e68c8801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Escalade Acetabular System
• Version Model Number: 170-0368
• 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: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter
• Outer Diameter: 68 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409017256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103384

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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