Legend Acetabular Shell

GUDID 00822409038718

Multi Hole, 42 mm

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

• Primary Device ID: 00822409038718
• NIH Device Record Key: ccc63935-49e2-4e46-87d9-61559092ab2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legend Acetabular Shell
• Version Model Number: 170-0642
• 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

Device Dimensions

• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter
• Outer Diameter: 42 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409038718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161080

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-14
• Device Publish Date: 2019-05-06

On-Brand Devices [Legend Acetabular Shell]

• 00822409035380: No Hole, 70 mm
• 00822409035373: No Hole, 68 mm
• 00822409035366: No Hole, 66 mm
• 00822409035359: No Hole, 64 mm
• 00822409035342: No Hole, 62 mm
• 00822409035335: No Hole, 60 mm
• 00822409035328: No Hole, 58 mm
• 00822409035311: No Hole, 56 mm
• 00822409035304: No Hole, 54 mm
• 00822409035298: No Hole, 52 mm
• 00822409035281: No Hole, 50 mm
• 00822409035274: No Hole, 48 mm
• 00822409035267: No Hole, 46 mm
• 00822409035250: No Hole, 44 mm
• 00822409035243: No Hole, 42 mm
• 00822409035236: Three Hole, 70 mm
• 00822409035229: Three Hole, 68 mm
• 00822409035212: Three Hole, 66 mm
• 00822409035205: Three Hole, 64 mm
• 00822409035199: Three Hole, 62 mm
• 00822409035182: Three Hole, 60 mm
• 00822409035175: Three Hole, 58 mm
• 00822409035168: Three Hole, 56 mm
• 00822409035151: Three Hole, 54 mm
• 00822409035144: Three Hole, 52 mm
• 00822409035137: Three Hole, 50 mm
• 00822409035120: Three Hole, 48 mm
• 00822409035113: Three Hole, 46 mm
• 00822409035106: Three Hole, 44 mm
• 00822409035090: Three Hole, 42 mm
• 00822409038855: Multi Hole, 70 mm
• 00822409038848: Multi Hole, 68 mm
• 00822409038831: Multi Hole, 66 mm
• 00822409038824: Multi Hole, 64 mm
• 00822409038817: Multi Hole, 62 mm
• 00822409038800: Multi Hole, 60 mm
• 00822409038794: Multi Hole, 58 mm
• 00822409038787: Multi Hole, 56 mm
• 00822409038770: Multi Hole, 54 mm
• 00822409038763: Multi Hole, 52 mm
• 00822409038756: Multi Hole, 50 mm
• 00822409038749: Multi Hole, 48 mm
• 00822409038732: Multi Hole, 46 mm
• 00822409038725: Multi Hole, 44 mm
• 00822409038718: Multi Hole, 42 mm