N/A 905483

GUDID 00885556076101

CANNULATED OSTEO BLADE PLATE ADOLESCENT 3 HOLE 50M

Smith & Nephew, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00885556076101
• NIH Device Record Key: 5e108963-3ab5-443e-a53f-09b60c6e2beb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 905483
• Catalog Number: 905483
• 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)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	00885556076101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993289

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-23

On-Brand Devices [N/A]

• 20817470011634: PASSING PIN W DRILL TIP 425MM(17IN)X2.4MM
• 00817470011401: FINAL ASSY HANDSWITCH ARTHROCARE SRVC
• 00817470011326: FINAL ASSEMBLY POWER CORD DOMESTIC SRVC
• 00817470011296: FINAL ASSEMBLY POWER CORD INTL SRVC
• 20817470011252: TOURNIQUET LIMB DRAPE-SMALL
• 20817470011245: TOURNIQUET LIMB DRAPE
• 00817470011166: ANATOMIC ACL STERILIZATION TRAY
• 00817470011159: 2.8MM PATHFINDER
• 00817470011142: 1.8MM PATHFINDER
• 00817470011135: TIBIAL BUTTON IMPACTOR
• 00817470011128: TIBIAL DILATOR
• 00817470011111: 6.5MM TIBIAL DRILL
• 00817470011098: 7.0 - 8.5 TIBIAL PIN GUIDE BODY
• 00817470011081: KNOT PUSHER
• 00817470011074: 40MM PEEK TIBIAL IMPLANT
• 00817470011067: REUSABLE BONE PUNCH 2.8MM Q-FIX IMPLANT
• 00817470011050: DISPOSABLE KIT 2.8MM SHOULDER Q-FIX
• 00817470011036: DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX
• 00817470011029: 2.8MM Q-FIX ALL SUTURE ANCHOR
• 00817470011012: 1.8MM Q-FIX ALL SUTURE ANCHOR
• 00817470011005: 33MM PEEK TIBIAL IMPLANT
• 00817470010992: N8TIVE ACL FEMORAL IMPLANT
• 00817470010985: ACL DISPOSABLE KIT
• 00817470010930: DEPTH GAGE
• 00817470010923: FEMORAL FOOTPRINT TEMPLATE
• 00817470010916: TIBIAL TAMP- SIZE 10.0
• 00817470010909: TIBIAL TAMP- SIZE 9.5
• 00817470010893: TIBIAL TAMP- SIZE 9.0
• 00817470010886: TIBIAL TAMP- SIZE 8.5
• 00817470010879: TIBIAL TAMP- SIZE 8.0
• 00817470010862: TIBIAL TAMP- SIZE 7.5
• 00817470010855: TIBIAL TAMP- SIZE 7.0
• 00817470010848: TAMP EXTENDER
• 00817470010831: SLOTTED MALLET
• 00817470010824: FEMORAL TAMP SIZE 10.0
• 00817470010817: FEMORAL TAMP SIZE 9.5
• 00817470010800: FEMORAL TAMP SIZE 9.0
• 00817470010794: FEMORAL TAMP SIZE 8.5
• 00817470010787: FEMORAL TAMP SIZE 8.0
• 00817470010770: FEMORAL TAMP SIZE 7.5
• 00817470010763: FEMORAL TAMP SIZE 7.0
• 00817470010749: TIBIAL SPACER INSERTER
• 00817470010732: IMPLANT EXTRACTOR
• 00817470010725: CURETTE
• 00817470010718: CLOSED TENDON HARVESTER
• 00817470010701: SLOTTED TENDON HARVESTER
• 00817470010695: GRAFT SIZING BLOCK
• 00817470010688: TUNNEL RASP
• 00817470010671: TIBIAL DRILL GUIDE ARM
• 00817470010664: TIBIAL PIN GUIDE