Consensus Knee System 2964-0-1002

GUDID 00840286846523

Patella, Round, Trial, UHMWPE, 10mm sz 2

Shalby Advanced Technologies, Inc.

Patella prosthesis trial

• Primary Device ID: 00840286846523
• NIH Device Record Key: a17edb96-d63a-45ed-83f0-ad74486759f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consensus Knee System
• Version Model Number: 2964-0-1002
• Catalog Number: 2964-0-1002
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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 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	00840286846523 [Primary]

FDA Product Code

• HWT: Template

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

[00840286846523]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

On-Brand Devices [Consensus Knee System]

• 00840286815444: Tibial Insert, PCL Substituting, R, 5-6, 22mm
• 00840286815437: Tibial Insert, PCL Substituting, R, 5-6, 20mm
• 00840286815420: Tibial Insert, PCL Substituting, R, 5-6, 18mm
• 00840286815413: Tibial Insert, PCL Substituting, R, 5-6, 16mm
• 00840286815406: Tibial Insert, PCL Substituting, R, 5-6, 14mm
• 00840286815390: Tibial Insert, PCL Substituting, R, 5-6, 12mm
• 00840286815383: Tibial Insert, PCL Substituting, R, 5-6, 10mm
• 00840286815376: Tibial Insert, PCL Substituting, R, 3-4, 22mm
• 00840286815369: Tibial Insert, PCL Substituting, R, 3-4, 20mm
• 00840286815352: Tibial Insert, PCL Substituting, R, 3-4, 18mm
• 00840286815345: Tibial Insert, PCL Substituting, R, 3-4, 16mm
• 00840286815338: Tibial Insert, PCL Substituting, R, 3-4, 14mm
• 00840286815321: Tibial Insert, PCL Substituting, R, 3-4, 12mm
• 00840286815314: Tibial Insert, PCL Substituting, R, 3-4, 10mm
• 00840286815307: Tibial Insert, PCL Substituting, R, 1-2, 22mm
• 00840286815291: Tibial Insert, PCL Substituting, R, 1-2, 20mm
• 00840286815284: Tibial Insert, PCL Substituting, R, 1-2, 18mm
• 00840286815277: Tibial Insert, PCL Substituting, R, 1-2, 16mm
• 00840286815260: Tibial Insert, PCL Substituting, R, 1-2, 14mm
• 00840286815253: Tibial Insert, PCL Substituting, R, 1-2, 12mm
• 00840286815246: Tibial Insert, PCL Substituting, R, 1-2, 10mm
• 00840286815239: Tibial Insert, PCL Substituting, R, 0, 22mm
• 00840286815222: Tibial Insert, PCL Substituting, R, 0, 20mm
• 00840286815215: Tibial Insert, PCL Substituting, R, 0, 18mm
• 00840286815208: Tibial Insert, PCL Substituting, R, 0, 16mm
• 00840286815192: Tibial Insert, PCL Substituting, R, 0, 14mm
• 00840286815185: Tibial Insert, PCL Substituting, R, 0, 12mm
• 00840286815178: Tibial Insert, PCL Substituting, R, 0, 10mm
• 00840286815161: Tibial Insert, PCL Substituting, R, 5-6, 18mm
• 00840286815154: Tibial Insert, PCL Substituting, R, 5-6, 16mm
• 00840286815147: Tibial Insert, PCL Substituting, R, 5-6, 14mm
• 00840286815130: Tibial Insert, PCL Substituting, R, 5-6, 12mm
• 00840286815123: Tibial Insert, PCL Substituting, R, 5-6, 10mm
• 00840286815116: Tibial Insert, PCL Substituting, R, 3-4, 18mm
• 00840286815109: Tibial Insert, PCL Substituting, R, 3-4, 16mm
• 00840286815093: Tibial Insert, PCL Substituting, R, 3-4, 14mm
• 00840286815086: Tibial Insert, PCL Substituting, R, 3-4, 12mm
• 00840286815079: Tibial Insert, PCL Substituting, R, 3-4, 10mm
• 00840286815062: Tibial Insert, PCL Substituting, R, 1-2, 22mm
• 00840286815055: Tibial Insert, PCL Substituting, R, 1-2, 20mm
• 00840286815048: Tibial Insert, PCL Substituting, R, 1-2, 18mm
• 00840286815031: Tibial Insert, PCL Substituting, R, 1-2, 16mm
• 00840286815024: Tibial Insert, PCL Substituting, R, 1-2, 14mm
• 00840286815017: Tibial Insert, PCL Substituting, R, 1-2, 12mm
• 00840286815000: Tibial Insert, PCL Substituting, R, 1-2, 10mm
• 00840286814997: Tibial Insert, PCL Substituting, L, 5-6, 22mm
• 00840286814980: Tibial Insert, PCL Substituting, L, 5-6, 20mm
• 00840286814973: Tibial Insert, PCL Substituting, L, 5-6, 18mm
• 00840286814966: Tibial Insert, PCL Substituting, L, 5-6, 16mm
• 00840286814959: Tibial Insert, PCL Substituting, L, 5-6, 14mm