Balanced Knee System Revision

GUDID 00822409095681

Tibial Augment 5mm Block Rt. Lat/Lt Med Sz 6

Ortho Development Corporation

Knee arthroplasty wedge

• Primary Device ID: 00822409095681
• NIH Device Record Key: c4bccae9-ca3b-4f65-aba9-75949636bef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balanced Knee System Revision
• Version Model Number: 567-5106A
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409095681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031201

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-02
• Device Publish Date: 2021-01-25

On-Brand Devices [Balanced Knee System Revision]

• 00822409096244: Femoral Augment Posterior Sz 7 8mm
• 00822409096237: Femoral Augment Posterior Sz 7 4mm
• 00822409096220: Femoral Augment Posterior Sz 7 2mm
• 00822409096213: Femoral Augment Posterior Sz 6 8mm
• 00822409096206: Femoral Augment Posterior Sz 6 4mm
• 00822409096190: Femoral Augment Posterior Sz 6 2mm
• 00822409096183: Femoral Augment Posterior Sz 5 8mm
• 00822409096176: Femoral Augment Posterior Sz 5 4mm
• 00822409096169: Femoral Augment Posterior Sz 5 2mm
• 00822409096152: Femoral Augment Posterior Sz 4 8mm
• 00822409096145: Femoral Augment Posterior Sz 4 4mm
• 00822409096138: Femoral Augment Posterior Sz 4 2mm
• 00822409096121: Femoral Augment Posterior Sz 3 8mm
• 00822409096114: Femoral Augment Posterior Sz 3 4mm
• 00822409096107: Femoral Augment Posterior Sz 3 2mm
• 00822409096091: Femoral Augment Posterior Sz 2 8mm
• 00822409096084: Femoral Augment Posterior Sz 2 4mm
• 00822409096077: Femoral Augment Posterior Sz 2 2mm
• 00822409096060: Femoral Augment Posterior Sz 1 8mm
• 00822409096053: Femoral Augment Posterior Sz 1 4mm
• 00822409096046: Femoral Augment Posterior Sz 1 2mm
• 00822409096039: Femoral Augment Distal Sz 7 12mm
• 00822409096022: Femoral Augment Distal Sz 7 8mm
• 00822409096015: Femoral Augment Distal Sz 7 4mm
• 00822409096008: Femoral Augment Distal Sz 6 12mm
• 00822409095995: Femoral Augment Distal Sz 6 8mm
• 00822409095988: Femoral Augment Distal Sz 6 4mm
• 00822409095971: Femoral Augment Distal Sz 5 12mm
• 00822409095964: Femoral Augment Distal Sz 5 8mm
• 00822409095957: Femoral Augment Distal Sz 5 4mm
• 00822409095940: Femoral Augment Distal Sz 4 12mm
• 00822409095933: Femoral Augment Distal Sz 4 8mm
• 00822409095926: Femoral Augment Distal Sz 4 4mm
• 00822409095919: Femoral Augment Distal Sz 3 12mm
• 00822409095902: Femoral Augment Distal Sz 3 8mm
• 00822409095896: Femoral Augment Distal Sz 3 4mm
• 00822409095889: Femoral Augment Distal Sz 2 12mm
• 00822409095872: Femoral Augment Distal Sz 2 8mm
• 00822409095865: Femoral Augment Distal Sz 2 4mm
• 00822409095858: Femoral Augment Distal Sz 1 8mm
• 00822409095841: Femoral Augment Distal Sz 1 4mm
• 00822409095834: Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 7
• 00822409095827: Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 6
• 00822409095810: Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 5
• 00822409095803: Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 4
• 00822409095797: Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 3
• 00822409095780: Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 2
• 00822409095773: Tibial Augment 15mm Block Rt. Lat/Lt Med Sz 1
• 00822409095766: Tibial Augment 10mm Block Rt. Lat/Lt Med Sz 7
• 00822409095759: Tibial Augment 10mm Block Rt. Lat/Lt Med Sz 6