SOLAR 6948-0-609

GUDID 07613327135985

Radial Head Prosthesis

Howmedica Osteonics Corp.

Elbow radius prosthesis

• Primary Device ID: 07613327135985
• NIH Device Record Key: d4fce9e5-90fe-42c7-b64c-3254d90a3ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLAR
• Version Model Number: 6948-0-609
• Catalog Number: 6948-0-609
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327135985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001385

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, 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 [SOLAR]

• 07613327138313: Shoulder Humeral Offset Head
• 07613327138306: Elbow Axle Pin
• 07613327138283: Shoulder Keeled Glenoid
• 07613327138269: Shoulder Keeled Glenoid
• 07613327138238: Shoulder Keeled Glenoid
• 07613327138221: Elbow Axle Pin
• 07613327138214: Shoulder Pegged Glenoid Component
• 07613327138207: Shoulder Pegged Glenoid Component
• 07613327138191: Shoulder Pegged Glenoid Component
• 07613327138184: Shoulder Humeral Offset Head
• 07613327138177: Shoulder Keeled Glenoid
• 07613327138160: Shoulder Humeral Component
• 07613327138153: Shoulder Pegged Glenoid Component
• 07613327138146: Shoulder Humeral Offset Head
• 07613327138139: Shoulder Humeral Offset Head
• 07613327138122: Shoulder Humeral Offset Head
• 07613327138115: Shoulder Humeral Component
• 07613327138108: Shoulder Humeral Offset Head
• 07613327138092: Shoulder Humeral Component
• 07613327138085: Shoulder Humeral Offset Head
• 07613327138078: Shoulder Humeral Component
• 07613327138061: Shoulder Humeral Component
• 07613327138054: Shoulder Humeral Component
• 07613327138047: Shoulder Humeral Offset Head
• 07613327138030: Shoulder Humeral Component
• 07613327138023: Shoulder Humeral Head
• 07613327138016: Shoulder Humeral Component
• 07613327138009: Shoulder Humeral Component
• 07613327137996: Shoulder Humeral Head
• 07613327137989: Shoulder Humeral Component
• 07613327137972: Shoulder Humeral Component
• 07613327137965: Shoulder Humeral Head
• 07613327137958: Shoulder Humeral Component
• 07613327137941: Shoulder Humeral Component
• 07613327137934: Shoulder Humeral Head
• 07613327137927: Shoulder Humeral Component
• 07613327137910: Shoulder Humeral Head
• 07613327137903: Shoulder Humeral Head
• 07613327137897: Shoulder Bipolar Modular Head
• 07613327137880: Shoulder Humeral Head
• 07613327137873: Shoulder Humeral Head
• 07613327137866: Shoulder Humeral Head
• 07613327137859: Shoulder Humeral Head
• 07613327137842: Shoulder Humeral Head
• 07613327137835: Elbow Ulna Component
• 07613327137828: Shoulder Humeral Head
• 07613327137811: Shoulder Humeral Head
• 07613327137804: Shoulder Humeral Head
• 07613327137798: Shoulder Humeral Head
• 07613327137781: Shoulder Humeral Head