Legend Acetabular Shell

GUDID 00822409035380

No Hole, 70 mm

Ortho Development Corporation

Acetabular shell

• Primary Device ID: 00822409035380
• NIH Device Record Key: 4c67919b-837b-4174-af7e-788ad6c60da8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legend Acetabular Shell
• Version Model Number: 170-0470
• 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: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter
• Outer Diameter: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409035380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161080

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: 2016-10-05

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
• 00822409130573: Three Hole, 70 mm
• 00822409130566: Three Hole, 68 mm
• 00822409130559: Three Hole, 66 mm
• 00822409130542: Three Hole, 64 mm
• 00822409130535: Three Hole, 62 mm