SPH Cup 9057.20.532

GUDID 08033390021913

Trial Cup Dia=54mm - Acetabular Cup

LIMACORPORATE SPA

Acetabulum prosthesis trial, prefabricated, reusable

• Primary Device ID: 08033390021913
• NIH Device Record Key: 37660ba8-496c-49c9-b3c1-011538dc0b13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPH Cup
• Version Model Number: Trial Cup
• Catalog Number: 9057.20.532
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390021913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

FDA Product Code

• KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

[08033390021913]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-12-21
• Device Publish Date: 2016-07-27

On-Brand Devices [SPH Cup]

• 08033390021975: Trial Cup Dia=66mm - Acetabular Cup
• 08033390021968: Trial Cup Dia=64mm - Acetabular Cup
• 08033390021951: Trial Cup Dia=62mm - Acetabular Cup
• 08033390021944: Trial Cup Dia=60mm - Acetabular Cup
• 08033390021937: Trial Cup Dia=58mm - Acetabular Cup
• 08033390021920: Trial Cup Dia=56mm - Acetabular Cup
• 08033390021913: Trial Cup Dia=54mm - Acetabular Cup
• 08033390021906: Trial Cup Dia=52mm - Acetabular Cup
• 08033390021890: Trial Cup Dia=50mm - Acetabular Cup
• 08033390021883: Trial Cup Dia=48mm - Acetabular Cup
• 08033390021876: Trial Cup Dia=46mm - Acetabular Cup
• 08033390021869: Trial Cup Dia=44mm - Acetabular Cup