Legend

GUDID 00822409039456

Acetabular Liner +3 Neutral 36/52

Ortho Development Corporation

Acetabular shell

• Primary Device ID: 00822409039456
• NIH Device Record Key: 2421eff4-6d8e-4f0e-aeea-5991d325deaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legend
• Version Model Number: 174-3652
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: false
• 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: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter
• Lumen/Inner Diameter: 36 Millimeter
• Outer Diameter: 52 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409039456 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-17

On-Brand Devices [Legend]

• 00822409039937: Acetabular Liner Face Changing 28/52
• 00822409039920: Acetabular Liner Face Changing 28/50
• 00822409039913: Acetabular Liner Face Changing 28/48
• 00822409039906: Acetabular Liner Face Changing 28/46
• 00822409039890: Acetabular Liner Face Changing 28/44
• 00822409039883: Acetabular Liner Face Changing 28/42
• 00822409039876: Acetabular Liner Face Changing 40/64-70
• 00822409039869: Acetabular Liner Face Changing 40/62
• 00822409039852: Acetabular Liner Face Changing 40/60
• 00822409039845: Acetabular Liner Face Changing 40/58
• 00822409039838: Acetabular Liner Face Changing 40/56
• 00822409039821: Acetabular Liner Face Changing 40/54
• 00822409039814: Acetabular Liner Face Changing 36/64-70
• 00822409039807: Acetabular Liner Face Changing 36/62
• 00822409039791: Acetabular Liner Face Changing 36/60
• 00822409039784: Acetabular Liner Face Changing 36/58
• 00822409039777: Acetabular Liner Face Changing 36/56
• 00822409039760: Acetabular Liner Face Changing 36/54
• 00822409039753: Acetabular Liner Face Changing 36/52
• 00822409039746: Acetabular Liner Face Changing 36/50
• 00822409039739: Acetabular Liner Face Changing 32/64-70
• 00822409039722: Acetabular Liner Face Changing 32/62
• 00822409039715: Acetabular Liner Face Changing 32/60
• 00822409039708: Acetabular Liner Face Changing 32/58
• 00822409039692: Acetabular Liner Face Changing 32/56
• 00822409039685: Acetabular Liner Face Changing 32/54
• 00822409039678: Acetabular Liner Face Changing 32/52
• 00822409039661: Acetabular Liner Face Changing 32/50
• 00822409039654: Acetabular Liner Face Changing 32/48
• 00822409039647: Acetabular Liner Face Changing 32/46
• 00822409039630: Acetabular Liner Face Changing 28/64-70
• 00822409039623: Acetabular Liner Face Changing 28/62
• 00822409039616: Acetabular Liner Face Changing 28/60
• 00822409039609: Acetabular Liner + Face Changing 28/58
• 00822409039593: Acetabular Liner Face Changing 28/56
• 00822409039586: Acetabular Liner Face Changing 28/54
• 00822409039579: Acetabular Liner +3 Neutral 40/64-70
• 00822409039562: Acetabular Liner +3 Neutral 40/62
• 00822409039555: Acetabular Liner +3 Neutral 40/60
• 00822409039548: Acetabular Liner +3 Neutral 40/58
• 00822409039531: Acetabular Liner +3 Neutral 40/56
• 00822409039524: Acetabular Liner +3 Neutral 40/54
• 00822409039517: Acetabular Liner +3 Neutral 36/64-70
• 00822409039500: Acetabular Liner +3 Neutral 36/62
• 00822409039494: Acetabular Liner +3 Neutral 36/60
• 00822409039487: Acetabular Liner +3 Neutral 36/58
• 00822409039470: Acetabular Liner +3 Neutral 36/56
• 00822409039463: Acetabular Liner +3 Neutral 36/54
• 00822409039456: Acetabular Liner +3 Neutral 36/52
• 00822409039449: Acetabular Liner +3 Neutral 36/50