C6001

GUDID 03596010591555

JIG INSERT

Smith & Nephew, Inc.

Orthopaedic implant aiming arm
Primary Device ID03596010591555
NIH Device Record Keyaa1e0837-bfde-463d-b707-ed2f70d8bdf6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberC6001
Catalog NumberC6001
Company DUNS045483575
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 Usefalse
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)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
GS103596010591555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXTProsthesis, hip, semi-constrained, metal/metal, resurfacing

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


[03596010591555]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-09-07
Device Publish Date2015-09-28

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00885556915257 - NA2025-12-30 EM POSTERIOR SLOPE GUIDE SHORT
00885556915264 - NA2025-12-30 EM TIBIA ALIGNMENT TUBE MICRO SHORT
00885556915271 - NA2025-12-30 MACRO EM TIBIA ALIGNMENT TUBE SHORT
00885556915295 - NA2025-12-30 RM/LL TIBIA ALIGNMENT GUIDE SHORT
00885556915301 - NA2025-12-30 TIBIA ALIGNMENT ADJUSTMENT GUIDE SHORT
00885556915318 - NA2025-12-30 SYNC SHORT EXTRAMEDULLARY GUIDES MODULE
00885556900260 - TRIGEN MAX2025-12-26 TRIGEN MAX BUTTRESS PLATE - TI

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