Series 7000 7145-0009

GUDID 07613327044089

Standard Tibial Tray

Howmedica Osteonics Corp.

Coated knee tibia prosthesis

• Primary Device ID: 07613327044089
• NIH Device Record Key: ba41b93b-328a-4acc-a431-fc29b1fdd192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Series 7000
• Version Model Number: 7145-0009
• Catalog Number: 7145-0009
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327044089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033971

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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 [Series 7000]

• 07613327044119: Standard Tibial Tray
• 07613327044089: Standard Tibial Tray
• 07613327044072: Standard Tibial Tray
• 07613327044065: Standard Tibial Tray
• 07613327044034: Standard Tibial Tray
• 07613327044027: Standard Tibial Tray
• 07613327035612: Tibial Insert - Series P/S III
• 07613327035605: Tibial Insert - Series P/S III
• 07613327035599: Tibial Insert - Series P/S III
• 07613327035582: Tibial Insert - Series P/S III
• 07613327035575: Tibial Insert - Series P/S III
• 07613327035568: Tibial Insert - Series P/S III
• 07613327035551: Tibial Insert - Series P/S III
• 07613327035544: Tibial Insert - Series P/S III
• 07613327035537: Tibial Insert - Series P/S III
• 07613327035520: Tibial Insert - Series P/S III
• 07613327035513: Tibial Insert - Series P/S III
• 07613327035506: Tibial Insert - Series P/S III
• 07613327035490: Tibial Insert - Series P/S III
• 07613327035483: Tibial Insert - Series P/S III
• 07613327035476: Tibial Insert - Series P/S III
• 07613327035469: Tibial Insert - Series P/S III
• 07613327035452: Tibial Insert - Series P/S III
• 07613327035445: Tibial Insert - Series P/S III
• 07613327035438: Tibial Insert - Series P/S III
• 07613327035421: Tibial Insert - Series P/S III
• 07613327035414: Tibial Insert - Series P/S III
• 07613327035407: Tibial Insert - Series P/S III
• 07613327035391: Tibial Insert - Series P/S III
• 07613327035384: Tibial Insert - Series P/S III
• 07613327035377: Tibial Insert - Series P/S III
• 07613327035360: Tibial Insert - Series P/S III
• 07613327035353: Tibial Insert - Series P/S III
• 07613327035346: Tibial Insert - Series P/S III
• 07613327035339: Tibial Insert - Series P/S III
• 07613327035322: Tibial Insert - Series P/S III
• 07613327035315: Tibial Insert - Series P/S III
• 07613327035308: Tibial Insert - Series P/S III
• 07613327035292: Tibial Insert - Series P/S III
• 07613327035285: Tibial Insert - Series P/S III
• 07613327035278: Tibial Insert - Series P/S III
• 07613327035261: Tibial Insert - Series P/S II
• 07613327035254: Tibial Insert - Series P/S II
• 07613327035247: Tibial Insert - Series P/S II
• 07613327035230: Tibial Insert - Series P/S II
• 07613327035223: Tibial Insert - Series P/S II
• 07613327035216: Tibial Insert - Series P/S II
• 07613327035209: Tibial Insert - Series P/S II
• 07613327035193: Tibial Insert - Series P/S II
• 07613327035186: Tibial Insert - Series P/S II