GMRS 6495-3-601

GUDID 07613327048896

Tibial Rotating Component

Howmedica Osteonics Corp.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 07613327048896
• NIH Device Record Key: fcfef72b-d657-4cd1-b2bf-e4e45fcb1216
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMRS
• Version Model Number: 6495-3-601
• Catalog Number: 6495-3-601
• 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 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	07613327048896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023087

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 [GMRS]

• 07613327142631: Distal Femoral Growing Prosthesis
• 07613327142624: Distal Femoral Growing Prosthesis
• 07613327142617: Distal Femoral Growing Prosthesis
• 07613327142600: Distal Femoral Growing Prosthesis
• 07613327142594: Distal Femoral Growing Prosthesis
• 07613327142587: Distal Femoral Growing Prosthesis
• 07613327142570: Distal Femoral Growing Prosthesis
• 07613327142563: Distal Femoral Growing Prosthesis
• 07613327142556: Distal Femoral Growing Prosthesis
• 07613327142549: Distal Femoral Growing Prosthesis
• 07613327142532: Distal Femoral Growing Prosthesis
• 07613327142525: Distal Femoral Growing Prosthesis
• 07613327049831: Extension Piece
• 07613327049824: Distal Femoral Component
• 07613327049800: Proximal Femoral Component
• 07613327049299: Extension Piece
• 07613327049282: Extension Piece
• 07613327049275: Extension Piece
• 07613327049268: Extension Piece
• 07613327049251: Extension Piece
• 07613327049244: Extension Piece
• 07613327049237: Extension Piece
• 07613327049220: Extension Piece
• 07613327049213: Connection Piece
• 07613327049206: Extension Piece
• 07613327049190: Extension Piece
• 07613327049176: Connection Piece
• 07613327049169: Extension Piece
• 07613327049152: Extension Piece
• 07613327049145: Connection Piece
• 07613327049121: Connection Piece
• 07613327048919: Proximal Tibia
• 07613327048896: Tibial Rotating Component
• 07613327048865: Proximal Tibia
• 07613327048858: Insert for Small Proximal Tibial Component
• 07613327048841: Bushing for Small Distal Femur
• 07613327048834: Insert for Small Proximal Tibial Component
• 07613327048827: Insert for Small Proximal Tibial Component
• 07613327048810: Insert for Small Proximal Tibial Component
• 07613327048803: Insert for Small Proximal Tibial Component
• 07613327048797: Distal Femoral Component
• 07613327048780: Distal Femoral Component
• 07613327048773: Axle
• 07613327048766: Proximal Femoral Component
• 07613327048759: Distal Femoral Component
• 07613327048735: Proximal Femoral Component
• 07613327048728: Proximal Femoral Component
• 07613327048711: Proximal Femoral Component
• 07613327048704: Proximal Femoral Component
• 07613327033748: Bowed Press-Fit Stem