Engage Partial Knee System

GUDID B6951100121000

Affinium 3D Coated Tibial Tray, Left Medial, Size 1

Engage UNI LLC

Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis

• Primary Device ID: B6951100121000
• NIH Device Record Key: a3355265-8064-4c1d-83a8-9ffd0a11c58b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Engage Partial Knee System
• Version Model Number: 1-10012-100
• Company DUNS: 088177182
• Company Name: Engage UNI LLC
• 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: 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: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 833-364-2432
• Email: info@engagesurgical.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com
• Phone: 1-800-238-7538
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6951100121000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190439

FDA Product Code

• NJD: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, 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: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [Engage Partial Knee System]

• B6951520100000: Revision Tray
• B6951520050000: Right Tray
• B6951520040000: Left Tray
• B6951520020000: General Tray 2
• B6951520010000: General Tray 1
• B695151095000A0: Quick Connect Handle
• B6951510950000: Quick Connect Handle
• B695151067000A0: Slap Hammer
• B6951510670000: Slap Hammer
• B695151060000A0: Femoral Impactor
• B6951510600000: Femoral Impactor
• B695151059000A0: Femoral Sizer Right Medial
• B6951510590000: Femoral Sizer Right Medial
• B695151058000A0: Femoral Sizer Left Medial
• B6951510580000: Femoral Sizer Left Medial
• B6951510550130: Insert Sizer 13mm
• B6951510550110: Insert Sizer 11mm
• B6951510550100: Insert Sizer 10mm
• B6951510550090: Insert Sizer 9mm
• B695151041007A0: Femoral Trial Right Medial Size 7
• B6951510410070: Femoral Trial Right Medial Size 7
• B695151041006A0: Femoral Trial Right Medial Size 6
• B6951510410060: Femoral Trial Right Medial Size 6
• B695151041005A0: Femoral Trial Right Medial Size 5
• B6951510410050: Femoral Trial Right Medial Size 5
• B695151041004A0: Femoral Trial Right Medial Size 4
• B6951510410040: Femoral Trial Right Medial Size 4
• B695151041003A0: Femoral Trial Right Medial Size 3
• B6951510410030: Femoral Trial Right Medial Size 3
• B695151041002A0: Femoral Trial Right Medial Size 2
• B6951510410020: Femoral Trial Right Medial Size 2
• B695151040007A0: Femoral Trial Left Medial Size 7
• B6951510400070: Femoral Trial Left Medial Size 7
• B695151040006A0: Femoral Trial Left Medial Size 6
• B6951510400060: Femoral Trial Left Medial Size 6
• B695151040005A0: Femoral Trial Left Medial Size 5
• B6951510400050: Femoral Trial Left Medial Size 5
• B695151040004A0: Femoral Trial Left Medial Size 4
• B6951510400040: Femoral Trial Left Medial Size 4
• B695151040003A0: Femoral Trial Left Medial Size 3
• B6951510400030: Femoral Trial Left Medial Size 3
• B695151040002A0: Femoral Trial Left Medial Size 2
• B6951510400020: Femoral Trial Left Medial Size 2
• B695151037004A0: Femoral Downsizing Guide Right Medial 4 Only
• B6951510370040: Femoral Downsizing Guide Right Medial 4 Only
• B695151037001A0: Femoral Downsizing Guide Right Medial 2-3 / 5-8
• B6951510370010: Femoral Downsizing Guide Right Medial 2-3 / 5-8
• B695151036004A0: Femoral Downsizing Guide Left Medial 4 Only
• B6951510360040: Femoral Downsizing Guide Left Medial 4 Only
• B695151036001A0: Femoral Downsizing Guide Left Medial 2-3 / 5-8