MRH 6497-2-303

GUDID 07613327033786

Tibial Bearing Component

Howmedica Osteonics Corp.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 07613327033786
• NIH Device Record Key: 5fae4808-a3bb-49b2-bc8d-d2a2439cb547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MRH
• Version Model Number: 6497-2-303
• Catalog Number: 6497-2-303
• 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	07613327033786 [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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-09-24

On-Brand Devices [MRH]

• 07613327101089: Knee Tibial Baseplate
• 07613327101065: Knee Tibial Baseplate
• 07613327101058: Knee Tibial Baseplate
• 07613327101041: Knee Tibial Baseplate
• 07613327050097: MRH Knee Femoral Distal Block
• 07613327050080: MRH Knee Femoral Distal Block
• 07613327050073: MRH Knee Femoral Distal Block
• 07613327050066: MRH Knee Femoral Distal Block
• 07613327050059: MRH Knee Femoral Distal Block
• 07613327045376: MRH Knee Femoral Component
• 07613327045338: MRH Knee Tibial Baseplate
• 07613327045321: MRH Knee Tibial Baseplate
• 07613327045314: MRH Knee Tibial Baseplate
• 07613327045307: MRH Knee Tibial Baseplate
• 07613327045291: MRH Bushings, Sleeve, Neutral Bumper
• 07613327045284: MRH Knee Tibial Sleeve
• 07613327045277: MRH Knee Bumper Insert
• 07613327045260: MRH Knee Bumper Insert
• 07613327045253: Modular Rotating Hinge Knee-Axle
• 07613327045246: MRH Knee Femoral Bushing
• 07613327045239: MRH Tibial Bearing Component
• 07613327045222: MRH Tibial Bearing Component
• 07613327045215: MRH Tibial Rotating Component
• 07613327045208: MRH Tibial Rotating Component
• 07613327045192: MRH Knee Femoral Component
• 07613327045185: MRH Knee Femoral Component
• 07613327045178: MRH Knee Femoral Component
• 07613327045161: MRH Knee Femoral Component
• 07613327045154: MRH Knee Femoral Component
• 07613327045147: MRH Knee Femoral Component
• 07613327045130: MRH Knee Femoral Component
• 07613327045123: MRH Knee Femoral Component
• 07613327045109: MRH Knee Femoral Component
• 07613327043884: MRH Knee Tibial Insert
• 07613327043860: MRH Knee Tibial Insert
• 07613327043853: MRH Knee Tibial Insert
• 07613327043846: MRH Knee Tibial Insert
• 07613327043839: MRH Knee Tibial Insert
• 07613327043822: MRH Knee Tibial Insert
• 07613327043815: MRH Knee Tibial Insert
• 07613327043808: MRH Knee Tibial Insert
• 07613327043792: MRH Knee Tibial Insert
• 07613327043785: MRH Knee Tibial Insert
• 07613327043778: MRH Tibial Bearing Component
• 07613327033786: Tibial Bearing Component
• 07613327033762: Tibial Bearing Component
• 07613327033755: Tibial Bearing Component