Endo-Knees E0016320-1

GUDID 00885556737743

SUTUREFIX CURVED CROWN TIP GUIDE

Smith & Nephew, Inc.

Surgical drill guide, reusable
Primary Device ID00885556737743
NIH Device Record Key98e89187-a80a-4410-8d6e-b2e6684ec41f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo-Knees
Version Model NumberE0016320-1
Catalog NumberE0016320-1
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556737743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, fixation, nondegradable, soft tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


[00885556737743]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-22
Device Publish Date2019-01-22

Devices Manufactured by Smith & Nephew, Inc.

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00885556906941 - EVOS2025-10-01 EVOS PELVIC 3.5MM LOCKING CURVED RECON PLATE 10 HOLE
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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