FOUNDATION® HIP SYSTEM

GUDID 00888912110662

Foundation PS Femur, NonPorous, TiNbN Coated, Sz 7 RT

Encore Medical, L.P.

Coated hip femur prosthesis, modular

• Primary Device ID: 00888912110662
• NIH Device Record Key: 4a93784e-82d8-476f-88c4-2638c873ffde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOUNDATION® HIP SYSTEM
• Version Model Number: 214-09-007
• Company DUNS: 154074504
• Company Name: Encore Medical, L.P.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888912110662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122239

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-03

Devices Manufactured by Encore Medical, L.P.

• 00190446872016 - DJO SURGICAL: 2024-04-23 SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL TOP INSERT
• 00190446872023 - DJO SURGICAL: 2024-04-23 SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL, SM
• 00190446872030 - DJO SURGICAL: 2024-04-23 SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL, MD
• 00190446872047 - DJO SURGICAL: 2024-04-23 SPECIAL, EMPOWR REVISION KNEE KEEL TRIAL, LG
• 00190446821700 - DJO SURGICAL: 2024-04-09 Reverse 25 in-lb Torque Limiting Driver
• 00190446765769 - DJO SURGICAL: 2024-04-01 CURVED RASP
• 00190446767459 - DJO SURGICAL: 2024-02-29 SPECIAL, ALT REV TRIAL SHELL W/ENHANCED ATTACHMENT, SMALL
• 00190446857655 - DJO SURGICAL: 2024-02-20 SPECIAL, EXPRT REVISION HIP DISTAL STEM TRIAL, SZ 14 X 130MM