GENESIS II 71925007

GUDID 03596010450395

GEN I/II CRUCIATE RETAINING ART ISRT SZ 7-8 18MM

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 03596010450395
• NIH Device Record Key: 4ae0e1e3-8ad0-4019-aca9-5d6a332859c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESIS II
• Version Model Number: 71925007
• Catalog Number: 71925007
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)821-5700
• 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	03596010450395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871146

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: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [GENESIS II]

• 00885556728857: P/S REAMING COLLET SZ 4
• 00885556728840: CHISEL SPACER H-BLOCK
• 00885556727256: ALIGNMENT PLATE LONG & WIDE ARMS
• 00885556727249: GENESIS II TIBIAL TRAY IMPLANT IMPACTOR W ALIGNMENT
• 00885556727225: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 8 RT
• 00885556727218: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 7 RT
• 00885556727201: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 6 RT
• 00885556727195: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 5 RT
• 00885556727188: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 4 RT
• 00885556727171: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 3 RT
• 00885556727164: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 2 RT
• 00885556727157: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 8 LT
• 00885556727140: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 7 LT
• 00885556727133: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 6 LT
• 00885556727126: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 5 LT
• 00885556727119: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 4 LT
• 00885556727102: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 3 LT
• 00885556727096: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 2 LT
• 00885556726723: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 5 RT
• 00885556726716: STEMLESS TIBIAL TRIAL W/ ANT PIN HOLES SIZE 4 RT
• 00885556726488: THINNED SPACER BLOCK
• 00885556675250: GII REAM THROUGH FEMORAL TRIAL SZ5 LEFT
• 00885556671306: LONGER SPIKED DCF VALGUS ALIGNMENT GUIDE
• 00885556651414: 32MM ROUND PATELLA PROTECTOR W/ SPIKES
• 00885556651315: 29MM GII PATELLA PROTECTOR W/ PEGS
• 00885556651308: 26MM GII PATELLA PROTECTOR WITH PEGS
• 00885556650295: 10MM X 70MM STEM TRIAL
• 00885556650288: 14MM REAMER WITH A POSITIVE STOP FOR 10MM X 70MM STEM
• 00885556648568: Tibia Trial with Anterior Pin Holes Sz 1 Left
• 00885556648551: TIBIA TRIAL WITH ANTERIOR PIN HOLES SZ 1 RIGHT
• 00885556647974: 35MM OVAL PATELLA PROTECTOR GENESIS II
• 00885556647967: 29 MM OVAL PATELLAR PROTECTOR GENESIS II
• 00885556647875: SIZE 8 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
• 00885556647868: SIZE 7 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
• 00885556647851: SIZE 6 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
• 00885556647844: SIZE 5 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
• 00885556647837: SIZE 4 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
• 00885556647820: SIZE 3 AP CUTTING BLOCKS WITH CRUCIATE SPIKES
• 00885556645680: FEMORAL DOWNSIZING DRILL GUIDE WITH 1 &3 MM HOLES ADDED
• 00885556635247: CRUCIATE RETAINING DISHED TRIAL INSERT 7-8 11MM
• 00885556635230: CRUCIATE RETAINING DISHED TRIAL INSERT 5-6 11MM
• 00885556635223: CRUCIATE RETAINING DISHED TRIAL INSERT 3-4 11MM
• 00885556635216: CRUCIATE RETAINING DISHED TRIAL INSERT 1-2 11MM
• 00885556635209: CRUCIATE RETAINING DISHED TRIAL INSERT 7-8 9MM
• 00885556635193: CRUCIATE RETAINING DISHED TRIAL INSERT 5-6 9MM
• 00885556635186: CRUCIATE RETAINING DISHED TRIAL INSERT 3-4 9MM
• 00885556635179: CRUCIATE RETAINING DISHED TRIAL INSERT 1-2 9MM
• 00885556635162: CONSTRAINED TRIAL INSERT 7-8 11MM
• 00885556635155: CONSTRAINED TRIAL INSERT 5-6 11MM
• 00885556635148: CONSTRAINED TRIAL INSERT 3-4 11MM