014896

GUDID 03596010026781

SMALL JOINT OSTEOTOME

Smith & Nephew, Inc.

Orthopaedic osteotome
Primary Device ID03596010026781
NIH Device Record Key9fb7851b-c41b-40ba-a082-06eb18360955
Commercial Distribution StatusIn Commercial Distribution
Version Model Number014896
Catalog Number014896
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)821-5700
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
GS103596010026781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


[03596010026781]

Moist Heat or Steam Sterilization


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.

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
00885556907306 - EVOS2025-10-01 EVOS PELVIC 2.7MM/3.5MM SYMPHYSIS LOCKING PLATE TABBED 6 HOLE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.