HMRS 6465-6-007

GUDID 07613327048933

Wedge

Howmedica Osteonics Corp.

Uncoated hip femur prosthesis, modular

• Primary Device ID: 07613327048933
• NIH Device Record Key: 552362aa-1a2e-471d-9975-3f51e8e4aa55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMRS
• Version Model Number: 6465-6-007
• Catalog Number: 6465-6-007
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327048933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122015

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [HMRS]

• 07613327049930: Axis Pin
• 07613327048933: Wedge
• 07613327048216: Bearing
• 04546540276520: G I-II. CIRCLIPS