Knee-Misc E0016907-2

GUDID 00885556779927

TIBIAL RESECTION GUIDE - 0 DEGREE

Smith & Nephew, Inc.

Osteotomy guide

• Primary Device ID: 00885556779927
• NIH Device Record Key: 99278dd3-f298-40a9-80f5-0e635798f9cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knee-Misc
• Version Model Number: E0016907-2
• Catalog Number: E0016907-2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556779927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121393

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

[00885556779927]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-20
• Device Publish Date: 2020-03-12

On-Brand Devices [Knee-Misc]

• 00885556640470: SHORT QUICK CONNECT HANDLE
• 00885556640456: PATELLA RESECTION GUIDE
• 00885556779941: TIBIAL RESECTION GUIDE - 7 DEGREE
• 00885556779934: TIBIAL RESECTION GUIDE - 5 DEGREE
• 00885556779927: TIBIAL RESECTION GUIDE - 0 DEGREE
• 00885556779903: TIBIA IM JIG ASSEMBLY