71021025

GUDID 03596010170927

TITANIUM HALF PIN 6MM X 35MM

Smith & Nephew, Inc.

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID03596010170927
NIH Device Record Key51c791d7-7a4d-4277-b95c-5fddc5e76d9f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71021025
Catalog Number71021025
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010170927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


[03596010170927]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-11-03
Device Publish Date2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

00885556918074 - Trigen2024-04-25 LAG SCREW DRIVER W/ HALL-JACOBS ADAPTER
00885556917435 - Real Intelligence2024-04-18 RI.KNEE ROBOTICS V3.0
00885556918036 - Trigen2024-04-18 8MM END CUTTING REAMER HEAD
00885556918043 - Trigen2024-04-18 8.5MM END CUTTING REAMER HEAD
00885556918050 - Polar2024-04-18 POLAR CALCAR PLANER - 40MM
00885556918067 - Polar2024-04-18 POLAR CALCAR PLANER - 45MM
00885556918029 - Trigen2024-04-16 DRILL SLEEVE DEPTH GAUGE
00885556917978 - Legion2024-04-10 EM PROXIMAL GUIDE - L

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.