PIGALILEO/TC-PLUS/RT-PLUS 75009310

GUDID 07611996073270

PIGALILEO TKR AO ADAPTER FOR SPEED-PIN

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 07611996073270
• NIH Device Record Key: 186a9c42-c2b7-4de1-bc23-881076901b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIGALILEO/TC-PLUS/RT-PLUS
• Version Model Number: 75009310
• Catalog Number: 75009310
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: 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

Customer Support Contacts

• 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
• 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
• 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
• 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
GS1	07611996073270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113038

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

[07611996073270]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-13

On-Brand Devices [PIGALILEO/TC-PLUS/RT-PLUS]

• 07611996100549: PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 110(6X)
• 07611996100532: PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 80 (6X)
• 07611996100525: PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 65 (6X)
• 07611996073270: PIGALILEO TKR AO ADAPTER FOR SPEED-PIN