CoCrMo 5010.09.322

GUDID 08033390006859

Modular femoral heads (CoCrMo) Dia. 32mm M Taper 12/14

LIMACORPORATE SPA

Metallic femoral head prosthesis

• Primary Device ID: 08033390006859
• NIH Device Record Key: f731aaff-979c-4881-8819-a38c4d711c33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoCrMo
• Version Model Number: Femoral Head
• Catalog Number: 5010.09.322
• 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: 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390006859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

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: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-07-31

On-Brand Devices [CoCrMo ]

• 08033390006934: Modular femoral heads (CoCrMo) Dia. 36mm XL Taper 12/14
• 08033390006927: Modular femoral heads (CoCrMo) Dia. 36mm L Taper 12/14
• 08033390006910: Modular femoral heads (CoCrMo) Dia. 36mm M Taper 12/14
• 08033390006903: Modular femoral heads (CoCrMo) Dia. 36mm S Taper 12/14
• 08033390006873: Modular femoral heads (CoCrMo) Dia. 32mm XL Taper 12/14
• 08033390006866: Modular femoral heads (CoCrMo) Dia. 32mm L Taper 12/14
• 08033390006859: Modular femoral heads (CoCrMo) Dia. 32mm M Taper 12/14
• 08033390006842: Modular femoral heads (CoCrMo) Dia. 32mm S Taper 12/14
• 08033390006811: Modular femoral heads (CoCrMo) Dia. 28mm XL Taper 12/14
• 08033390006804: Modular femoral heads (CoCrMo) Dia. 28mm L Taper 12/14
• 08033390006798: Modular femoral heads (CoCrMo) Dia. 28mm M Taper 12/14
• 08033390006781: Modular femoral heads (CoCrMo) Dia. 28mm S Taper 12/14