Accord 71930987

GUDID 03596010560841

ACCORD 320MM TITANIUM PLATE

Smith & Nephew, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 03596010560841
• NIH Device Record Key: 4ca0b2c3-a214-4331-8f71-abc48947d204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accord
• Version Model Number: 71930987
• Catalog Number: 71930987
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010560841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993106

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [Accord]

• 00885556738580: CABLE PASSER - LARGE
• 00885556738573: CABLE PASSER - SMALL
• 00885556636831: CABLE PASSER 004
• 00885556636824: CABLE PASSER 003
• 00885556636817: CABLE PASSER 002
• 00885556636800: CABLE PASSER 001
• 00885556158661: ACCORD INSTRUMENT CADDY
• 03596010611543: ACCORD DUAL ENDED HEX DRIVER
• 03596010568205: ACCORD PILOT SCREWDRIVER BIT
• 03596010560841: ACCORD 320MM TITANIUM PLATE
• 03596010525321: ACCORD LOW PROFILE CABLE SPIKE
• 03596010525314: ACC STAINLESS STEEL CABLE SCREW
• 03596010525307: ACCORD STAINLESS STEEL CABLE SPIKE
• 03596010500298: ACCORD 250MM TITANIUM PLATE
• 03596010500281: ACCORD 200MM TITANIUM PLATE
• 03596010500274: ACCORD 150MM TITANIUM PLATE
• 03596010500267: ACCORD CABLE SYSTEM INSTRUMENT TRAY
• 03596010500243: ACCORD TORQUE LIMITING SCREWDRIVER HANDLE
• 03596010500236: ACCORD LARGE 30 DEGREE OFFSET CABLE PASSER
• 03596010485793: ACCORD STD 85MM 3 CABLE TROCH GRIP
• 03596010485779: ACCORD SMALL 185MM 8 CABLE TROCH GRIP
• 03596010485724: ACCORD 2.0MM COBALT CHROME CABLE
• 03596010485373: ACCORD 30 DEGREE OFFSET CABLE PASSER
• 03596010485366: ACCORD STRAIGHT CABLE PASSER
• 03596010485359: ACCORD TENSIONER
• 03596010001269: ACCORD CABLE SPIKE DRIVER
• 00885556781845: LARGE -30 DEG CABLE PASSER
• 00885556794197: SMALL -30 DEG CABLE PASSER
• 00885556794180: LARGE -30 DEG CABLE PASSER
• 03596010525291: ACCORD 2.0MM STAINLESS STEEL CABLE WITH CLAMP
• 03596010485731: ACCORD 2.0MM COBALT CHROME CABLE WITH CLAMP
• 03596010485496: ACCORD STANDARD 265MM 11 CABLE TROCHANTERIC GRIP TRIAL
• 03596010485489: ACCORD STANDARD 195MM 8 CABLE TROCHANTERIC GRIP TRIAL
• 03596010485472: ACCORD STD 125MM 5 CABLE TROCH GRIP TRIAL
• 03596010485465: ACCORD STANDARD 85MM 3 CABLE TROCHANTERIC GRIP TRIAL
• 03596010485458: ACCORD SMALL 255MM 11 CABLE TROCHANTERIC GRIP TRIAL
• 03596010485441: ACCORD SMALL 185MM 8 CABLE TROCHANTERIC GRIP TRIAL
• 03596010485434: ACCORD SMALL 115MM 5 CABLE TROCHANTERIC GRIP TRIAL
• 03596010485427: ACCORD SMALL 75MM 3 CABLE TROCH GRIP TRIAL
• 03596010485410: ACCORD TROCHANTERIC GRIP POSITIONER
• 03596010485403: ACCORD SCISSOR CUTTER
• 03596010485397: ACCORD FLUSH CUTTER
• 03596010525338: ACCORD LOW PROFILE CABLE SCREW
• 03596010485823: ACCORD STANDARD 265MM 11 CABLE TROCHANTERIC GRIP
• 03596010485816: ACCORD STANDARD 195MM 8 CABLE TROCHANTERIC GRIP
• 03596010485809: ACCORD STANDARD 125MM 5 CABLE TROCHANTERIC GRIP
• 03596010485786: ACCORD SMALL 255MM 11 CABLE TROCHANTERIC GRIP
• 03596010485755: ACCORD SMALL 115MM 5 CABLE TROCHANTERIC GRIP
• 03596010485748: ACCORD SMALL 75MM 3 CABLE TROCHANTERIC GRIP