MRS 6485-3-811

GUDID 07613327049787

Curved Cemented Stem

Howmedica Osteonics Corp.

Knee femur stem prosthesis

• Primary Device ID: 07613327049787
• NIH Device Record Key: 10cf2409-90db-408e-a7eb-1227f64f6992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRS
• Version Model Number: 6485-3-811
• Catalog Number: 6485-3-811
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: 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
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0
• Length: 127 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327049787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040749

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, 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: 2020-04-20
• Device Publish Date: 2015-09-24

On-Brand Devices [MRS]

• 07613327141337: Assembly Screw
• 07613327049817: Femoral Intercalary Stem
• 07613327049794: Tibial Module Stem Section
• 07613327049787: Curved Cemented Stem
• 07613327049770: Femoral Intercalary Stem
• 07613327049763: Humeral Module
• 07613327049756: Humeral Module
• 07613327049749: Humeral Module
• 07613327049732: Humeral Module
• 07613327049725: Humeral Module
• 07613327049718: Humeral Module
• 07613327049374: Straight Cemented Stem
• 07613327049367: Straight Cemented Stem
• 07613327049183: Humeral Intercalary Stem
• 07613327049138: Humeral Proximal Cap
• 07613327049114: Humeral Intercalary Stem
• 07613327049107: Humeral Intercalary Stem
• 07613327049091: Humeral Intercalary Stem
• 07613327049084: Humeral Intercalary Stem
• 07613327049077: Humeral Intercalary Stem
• 07613327049060: Humeral Module
• 07613327049053: Humeral Intercalary Stem
• 07613327049046: Humeral Module
• 07613327049039: Humeral Module
• 07613327049022: Humeral Module
• 07613327049015: Humeral Module
• 07613327049008: Humeral Module
• 07613327048995: Humeral Module
• 07613327048988: Humeral Module
• 07613327048971: Humeral Module
• 07613327048964: Humeral Module
• 07613327048957: Humeral Module
• 07613327048940: Humeral Module
• 07613327048742: Humeral Intercalary Stem
• 07613327048698: Pediatric Tibial Bearing Component
• 07613327048681: Humeral Module
• 07613327048674: Tibial Module Stem Section
• 07613327048667: Humeral Module
• 07613327048650: Tibial Module Stem Section
• 07613327048643: Tibial Module Stem Section
• 07613327048636: Tibial Module Stem Section
• 07613327048629: Tibial Module Stem Section
• 07613327048612: Curved Cemented Stem
• 07613327048605: Curved Cemented Stem
• 07613327048599: Curved Cemented Stem
• 07613327048582: Curved Cemented Stem
• 07613327048575: Curved Cemented Stem
• 07613327048568: Curved Cemented Stem
• 07613327048551: Long Curved Cemented Stem
• 07613327048544: Curved Cemented Stem