013143

GUDID 03596010024701

FIXATION POST (BOX 1) STR

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID03596010024701
NIH Device Record Key148affc7-1149-474d-9f70-21fe7e60545a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number013143
Catalog Number013143
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010024701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

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00885556884027 - NA2026-03-02 LM/RL PROXIMAL TIBIA CADDY
00885556884034 - NA2026-03-02 RM/LL PROXIMAL TIBIA CADDY
00885556884140 - NA2026-03-02 JOURNEY II UK SHORT TIBIA ALIGNMENT CADDY
00885556920947 - NA2026-03-02 KINEMATIC ALIGNMENT MODULE
00885556920954 - NA2026-03-02 SPIKED EM/IM AND ADJUSTABLE FEMUR MODULE
00885556917794 - EVOS2025-12-31 EVOS 3.5MM X 54MM CORTEX SCREW SELF-TAPPING
00885556915257 - NA2025-12-30 EM POSTERIOR SLOPE GUIDE SHORT

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