Engage Partial Knee System

GUDID B6951100136090

Tibial Insert, Size 6, Left Medial, 9MM

Engage UNI LLC

Unicondylar knee prosthesis

• Primary Device ID: B6951100136090
• NIH Device Record Key: 91184043-9c23-48fe-8585-f6063876873e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Engage Partial Knee System
• Version Model Number: 1-10013-609
• 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	B6951100136090 [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