LOCK 5527.09.450

GUDID 08033390009737

Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 45 for head dia. 28 mm

LIMACORPORATE SPA

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 08033390009737
• NIH Device Record Key: 5711beee-468a-4122-8712-62e95113acc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOCK
• Version Model Number: Bipolar Head
• Catalog Number: 5527.09.450
• 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 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	08033390009737 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-07-31

On-Brand Devices [LOCK ]

• 08033390009850: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 57 for head dia. 28 mm
• 08033390009843: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 56 for head dia. 28 mm
• 08033390009836: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 55 for head dia. 28 mm
• 08033390009829: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 54 for head dia. 28 mm
• 08033390009812: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 53 for head dia. 28 mm
• 08033390009805: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 52 for head dia. 28 mm
• 08033390009799: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 51 for head dia. 28 mm
• 08033390009782: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 50 for head dia. 28 mm
• 08033390009775: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 49 for head dia. 28 mm
• 08033390009768: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 48 for head dia. 28 mm
• 08033390009751: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 47 for head dia. 28 mm
• 08033390009744: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 46 for head dia. 28 mm
• 08033390009737: Lock bipolar heads (CoCrMo + UHMWPE liner) Dia. 45 for head dia. 28 mm