71352116

GUDID 03596010619556

LEFT ANTEVERTED MODULAR NECK

Smith & Nephew, Inc.

Femoral stem prosthesis trial
Primary Device ID03596010619556
NIH Device Record Key53d38725-be8e-4cae-a9be-550d183dd2bf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71352116
Catalog Number71352116
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010619556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-31
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

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00885556907207 - EVOS2025-10-01 EVOS PELVIC 2.7MM SHORT SEGMENT CURVED UTILITY PLATE
00885556907214 - EVOS2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 2 HOLE
00885556907221 - EVOS2025-10-01 EVOS PELVIC 2.7/3.5MM SHORT SEGMENT CURVED UTILITY PLATE 4 HOLE
00885556907245 - EVOS2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 6 HOLE
00885556907252 - EVOS2025-10-01 EVOS PELVIC 3.5MM SYMPHYSIS NON-LOCKING PLATE STANDARD 8 HOLE
00885556907290 - EVOS2025-10-01 EVOS PELVIC 2.7MM/3.5MM SYMPHYSIS LOCKING PLATE TABBED 4 HOLE

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