P.C.A. 6728-1-611

GUDID 04546540322739

Modular Revision Insert

Howmedica Osteonics Corp.

Tibial insert

• Primary Device ID: 04546540322739
• NIH Device Record Key: 148a3b6e-757d-4107-89ec-8baee6f420cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.C.A.
• Version Model Number: 6728-1-611
• Catalog Number: 6728-1-611
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04546540322739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894403

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 [P.C.A.]

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• 07613154056064: Primary Insert
• 07613154056057: Primary Insert
• 07613154056040: Primary Insert
• 07613154056033: Primary Insert
• 07613154056026: Primary Insert
• 07613154056019: Primary Insert
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• 07613153132264: Primary Insert
• 04546540323163: All Poly Patella
• 04546540323156: Modular Revision Insert
• 04546540323149: Modular Revision Insert
• 04546540323132: Modular Revision Insert
• 04546540323125: Modular Revision Insert
• 04546540323118: Modular Revision Insert
• 04546540323101: Modular Revision Insert
• 04546540323095: Modular Revision Insert
• 04546540323088: Modular Revision Insert
• 04546540323071: Modular Revision Insert
• 04546540323064: Modular Revision Insert
• 04546540323057: Modular Revision Insert
• 04546540323040: Modular Revision Insert
• 04546540323033: Modular Revision Insert
• 04546540323026: Modular Revision Insert
• 04546540323019: All Poly Patella
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• 04546540322999: Modular Revision Insert
• 04546540322982: Modular Revision Insert
• 04546540322975: Modular Revision Insert
• 04546540322968: Modular Revision Insert
• 04546540322951: Modular Revision Insert
• 04546540322944: Modular Revision Insert
• 04546540322937: Modular Revision Insert
• 04546540322920: Modular Revision Insert
• 04546540322913: Modular Revision Insert
• 04546540322906: Modular Revision Insert
• 04546540322890: Modular Revision Insert
• 04546540322883: Modular Revision Insert
• 04546540322876: Modular Revision Insert
• 04546540322869: All Poly Patella
• 04546540322852: Modular Revision Insert
• 04546540322845: Modular Revision Insert
• 04546540322838: Modular Revision Insert
• 04546540322821: Modular Revision Insert
• 04546540322814: Modular Revision Insert
• 04546540322807: Modular Revision Insert
• 04546540322791: Modular Revision Insert
• 04546540322784: Modular Revision Insert
• 04546540322777: Modular Revision Insert
• 04546540322760: Modular Revision Insert