Kinemax 6476-8-180

GUDID 07613327050028

Tibial Wedge System-Fixation Peg

Howmedica Osteonics Corp.

Rotating hinged total knee prosthesis

• Primary Device ID: 07613327050028
• NIH Device Record Key: b8a32cdf-0dcb-4458-a8bb-1f97d1dd4b00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kinemax
• Version Model Number: 6476-8-180
• Catalog Number: 6476-8-180
• 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	07613327050028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964951

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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 [Kinemax]

• 07613327050035: Tibial Wedge System-Fixation Screw
• 07613327050028: Tibial Wedge System-Fixation Peg
• 07613327048131: Patella
• 07613327048124: Patella
• 07613327048117: Tibial Extension Stem
• 07613327048100: Tibial Extension Stem
• 07613327048094: Tibial Extension Stem
• 07613327048087: Tibial Wedge System
• 07613327048070: Tibial Wedge System
• 07613327048063: Tibial Wedge System
• 07613327048056: Tibial Wedge System
• 07613327048049: Tibial Wedge System
• 07613327048032: Tibial Wedge System
• 07613327048025: Tibial Wedge System
• 07613327048018: Tibial Wedge System
• 07613327048001: Tibial Full Block Wedge
• 07613327047998: Tibial Half Block Wedge
• 07613327047981: Tibial Half Block Wedge
• 07613327047974: Tibial Half Block Wedge
• 07613327047967: Tibial Half Block Wedge
• 07613327047950: Tibial Full Block Wedge
• 07613327047943: Tibial Half Block Wedge
• 07613327047936: Tibial Half Block Wedge
• 07613327047929: Tibial Half Block Wedge
• 07613327047912: Tibial Half Block Wedge
• 07613327047905: Tibial Full Block Wedge
• 07613327047899: Tibial Half Block Wedge
• 07613327047882: Tibial Half Block Wedge
• 07613327047875: Tibial Half Block Wedge
• 07613327047868: Tibial Half Block Wedge
• 07613327047851: Tibial Full Block Wedge
• 07613327047431: Tibial Stabiliser Bearing Insert
• 07613327047424: Tibial Stabiliser Bearing Insert
• 07613327047417: Tibial Stabiliser Bearing Insert
• 07613327047400: Tibial Stabiliser Bearing Insert
• 07613327047394: Tibial Stabiliser Bearing Insert
• 07613327047387: Tibial Stabiliser Bearing Insert
• 07613327047370: Tibial Stabiliser Bearing Insert
• 07613327047363: Tibial Stabiliser Bearing Insert
• 07613327047356: Tibial Stabiliser Bearing Insert
• 07613327047349: Tibial Stabiliser Bearing Insert
• 07613327047332: Tibial Stabiliser Bearing Insert
• 07613327047325: Tibial Stabiliser Bearing Insert
• 07613327047318: Tibial Stabiliser Bearing Insert
• 07613327047301: Tibial Stabiliser Bearing Insert
• 07613327047295: Tibial Stabiliser Bearing Insert
• 07613327047288: Tibial Stabiliser Bearing Insert
• 07613327047271: Tibial Stabiliser Bearing Insert
• 07613327047264: Tibial Stabiliser Bearing Insert
• 07613327047257: Tibial Stabiliser Bearing Insert