engagesurgical.com
smith-nephew.comEngage™ Partial Knee System
Engage UNI, LLC
ENGAGE UNI LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016249968 | 3016249968 | ENGAGE UNI LLC | 1 | N | 2020-04-25 | 3505 Lake Lynda Dr Building 300, Suite 206 Orlando FL US 32817 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B6951500780000 | Engage Partial Knee System - Tension Gauge | 1-800-238-7538 | gudid@smith-nephew.com |
| B6951510040050 | Engage Partial Knee System - Distal Cutting Guide Long, Left Medial | 833-364-2432 | info@engagesurgical.com |
| B6951510040050 | Engage Partial Knee System - Distal Cutting Guide Long, Left Medial | 1-800-238-7538 | gudid@smith-nephew.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 236872 | 1904777790 | K190439 | Engage™ Partial Knee System | NJD | 2019-11-21 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NJD | 1 | 2019-11-21 |
PMN#
GUDID#
Engage Partial Knee System - General Tray 1
2020-07-10
Engage Partial Knee System - General Tray 2
2020-07-10
Engage Partial Knee System - Left Tray
2020-07-10
Engage Partial Knee System - Right Tray
2020-07-10
Engage Partial Knee System - Revision Tray
2020-07-10
Engage Partial Knee System - Tension Gauge
2021-04-09
Engage Partial Knee System - Distal Cutting Guide Long, Left Medial
2021-03-01
Engage Partial Knee System - Distal Cutting Guide Long, Right Medial
2021-03-01
Engage Partial Knee System - Femoral Downsizing Guide, Universal, 2-3 & 5-8
2021-03-01
Engage Partial Knee System - Posterior Prep Guide - Universal
2021-03-01
Engage Partial Knee System - Tibial Anchor Guide Screw
2020-10-02
Engage Partial Knee System - Femoral Component, Size 5 - Right Medial
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 1, Left Medial, 9MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 1, Left Medial, 10MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 1, Left Medial, 11MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 1, Left Medial, 13MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 2, Left Medial, 9MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 2, Left Medial, 10MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 2, Left Medial, 11MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 2, Left Medial, 13MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 3, Left Medial, 9MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 3, Left Medial, 10MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 4, Right Medial, 10MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 4, Right Medial, 11MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 4, Right Medial, 13MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 5, Right Medial, 9MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 5, Right Medial, 10MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 5, Right Medial, 11MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 5, Right Medial, 13MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 6, Right Medial, 9MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 6, Right Medial, 10MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 6, Right Medial, 11MM
2020-07-10
Engage Partial Knee System - Tibial Insert, Size 6, Right Medial, 13MM
2020-07-10
Engage Partial Knee System - Tibial Cutting Block +1MM Left Medial
2020-07-10
Engage Partial Knee System - Tibial Cutting Block +2MM Left Medial
2020-07-10
Engage Partial Knee System - Tibial Cutting Block +2MM Left Medial
2020-07-10
Engage Partial Knee System - Tibial Cutting Block -2MM Left Medial
2020-07-10
Engage Partial Knee System - Tibial Cutting Block -2MM Left Medial
2020-07-10
Engage Partial Knee System - Tibial Cutting Block 0MM Left Medial Non Slotted
2020-07-10
Engage Partial Knee System - Tibial Cutting Block +1MM Left Medial Non Slotted
2020-07-10