Legion E0016388-15

GUDID 00885556741047

11MM TIBIAL TRIAL STEM PLUG SZ. 7-8 LEFT

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556741047
• NIH Device Record Key: 00e61dd4-9473-4036-9a39-c3884c522b52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legion
• Version Model Number: E0016388-15
• Catalog Number: E0016388-15
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556741047 [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

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

[00885556741047]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-18
• Device Publish Date: 2019-03-08

On-Brand Devices [Legion]

• 00885556741764: CAPTURELESS MIS AP CUTTING BLOCK SZ-8
• 00885556741757: CAPTURELESS MIS AP CUTTING BLOCK SZ-7
• 00885556741740: CAPTURELESS MIS AP CUTTING BLOCK SZ-6
• 00885556741733: CAPTURELESS MIS AP CUTTING BLOCK SZ-5
• 00885556741726: CAPTURELESS MIS AP CUTTING BLOCK SZ-4
• 00885556741702: CAPTURELESS MIS AP CUTTING BLOCK SZ-3
• 00885556741399: 2MM RECUT BLOCK
• 00885556741382: 2MM SHIM
• 00885556741351: STATIC FEMORAL LUG DRILL
• 00885556741085: HANDLE
• 00885556741078: 11MM TIBIAL TRIAL STEM PLUG SZ. 7-8 RIGHT
• 00885556741061: 11MM TIBIAL TRIAL STEM PLUG SZ. 5-6 RIGHT
• 00885556741054: 11MM TIBIAL TRIAL STEM PLUG SZ. 3-4 RIGHT
• 00885556741047: 11MM TIBIAL TRIAL STEM PLUG SZ. 7-8 LEFT
• 00885556741030: 11MM TIBIAL TRIAL STEM PLUG SZ. 5-6 LEFT
• 00885556741023: 11MM TIBIAL TRIAL STEM PLUG SZ. 3-4 LEFT
• 00885556741016: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 8 RIGHT
• 00885556741009: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 7 RIGHT
• 00885556740996: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 6 RIGHT
• 00885556740989: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 5 RIGHT
• 00885556740972: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 4 RIGHT
• 00885556740965: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 3 RIGHT
• 00885556740958: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 8 LEFT
• 00885556740941: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 7 LEFT
• 00885556740934: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 6 LEFT
• 00885556740927: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 5 LEFT
• 00885556740910: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 4 LEFT
• 00885556740903: TIBIAL TRIAL BASEPLATE W/ STEM POCKET SZ. 3 LEFT
• 00885556740835: 2 DEG. VARUS/VALGUS RECUT BLOCK
• 00885556740651: 0 DEGREE MIS TIBIA CUTTING BLOCK - RIGHT
• 00885556740644: 0 DEGREE MIS TIBIA CUTTING BLOCK - LEFT
• 00885556739969: 2MM RECUT BLOCK
• 00885556739914: LEGION MIS CUTTING BLOCK SZ 8
• 00885556739907: LEGION MIS CUTTING BLOCK SZ 7
• 00885556739891: LEGION MIS CUTTING BLOCK SZ 6
• 00885556739884: LEGION MIS CUTTING BLOCK SZ 5
• 00885556739877: LEGION MIS CUTTING BLOCK SZ 4
• 00885556739860: LEGION MIS CUTTING BLOCK SZ 3
• 00885556739853: BOX COLLET WITH SOLID SCREW SZ 6
• 00885556739839: GII MIS PATELLA PROTECTIVE CAP 41MM
• 00885556739822: GII MIS PATELLA PROTECTIVE CAP 38MM
• 00885556739815: GII MIS PATELLA PROTECTIVE CAP 35MM
• 00885556739792: GII MIS PATELLA PROTECTIVE CAP 32MM
• 00885556739785: GII MIS PATELLA PROTECTIVE CAP 29MM
• 00885556739761: AP CUTTING BLOCK - SZ 7
• 00885556739754: AP CUTTING BLOCK - SZ 4
• 00885556739747: FLEXIBLE IM ROD
• 00885556739266: MIS AP 4-IN-1 BLOCK W/SHORT SPIKES SZ 8
• 00885556739259: MIS AP 4-IN-1 BLOCK W/SHORT SPIKES SZ 7
• 00885556739242: MIS AP 4-IN-1 BLOCK W/SHORT SPIKES SZ 6