PIGALILEO/TC-PLUS/RT-PLUS 75009310

GUDID 07611996073270

PIGALILEO TKR AO ADAPTER FOR SPEED-PIN

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation 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