Cadence Total Ankle System 10209108

GUDID 00885556852668

CADENCE INSERT. SIZE 1. RIGHT. 8MM. NEUTRAL

Smith & Nephew, Inc.

Fixed-bearing total ankle prosthesis
Primary Device ID00885556852668
NIH Device Record Key722257be-adfa-492e-8e7c-8c1f7b6c543d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCadence Total Ankle System
Version Model Number10209108
Catalog Number10209108
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 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)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
GS100885556852668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2022-12-21

On-Brand Devices [Cadence Total Ankle System]

00885556854792CASE. CADENCE FLAT CUT INSTRUMENTS
00885556854808CASE. CADENCE FLAT CUT INSTRUMENTS. ALTERNATE
00885556852279CADENCE SIZE 5 INSERT TRIAL. 12MM
00885556852262CADENCE SIZE 5 INSERT TRIAL. 11MM
00885556852255CADENCE SIZE 5 INSERT TRIAL. 10MM
00885556852248CADENCE SIZE 5 INSERT TRIAL. 9MM
00885556852231CADENCE SIZE 5 INSERT TRIAL. 8MM
00885556852224CADENCE SIZE 5 INSERT TRIAL. 7MM
00885556852217CADENCE SIZE 5 INSERT TRIAL. 6MM
00885556852200CADENCE SIZE 4 INSERT TRIAL. 12MM
00885556852194CADENCE SIZE 4 INSERT TRIAL. 11MM
00885556852187CADENCE SIZE 4 INSERT TRIAL. 10MM
00885556852170CADENCE SIZE 4 INSERT TRIAL. 9MM
00885556852163CADENCE SIZE 4 INSERT TRIAL. 8MM
00885556852156CADENCE SIZE 4 INSERT TRIAL. 7MM
00885556852149CADENCE SIZE 4 INSERT TRIAL. 6MM
00885556852132CADENCE SIZE 3 INSERT TRIAL. 12MM
00885556852125CADENCE SIZE 3 INSERT TRIAL. 11MM
00885556852118CADENCE SIZE 3 INSERT TRIAL. 10MM
00885556852101CADENCE SIZE 3 INSERT TRIAL. 9MM
00885556852095CADENCE SIZE 3 INSERT TRIAL. 8MM
00885556852088CADENCE SIZE 3 INSERT TRIAL. 7MM
00885556852071CADENCE SIZE 3 INSERT TRIAL. 6MM
00885556852064CADENCE SIZE 2 INSERT TRIAL. 12MM
00885556852057CADENCE SIZE 2 INSERT TRIAL. 11MM
00885556852040CADENCE SIZE 2 INSERT TRIAL. 10MM
00885556852033CADENCE SIZE 2 INSERT TRIAL. 9MM
00885556852026CADENCE SIZE 2 INSERT TRIAL. 8MM
00885556852019CADENCE SIZE 2 INSERT TRIAL. 7MM
00885556852002CADENCE SIZE 2 INSERT TRIAL. 6MM
00885556851999CADENCE SIZE 1 INSERT TRIAL. 12MM
00885556851982CADENCE SIZE 1 INSERT TRIAL. 11MM
00885556851975CADENCE SIZE 1 INSERT TRIAL. 10MM
00885556851968CADENCE SIZE 1 INSERT TRIAL. 9MM
00885556851951CADENCE SIZE 1 INSERT TRIAL. 8MM
00885556851944CADENCE SIZE 1 INSERT TRIAL. 7MM
00885556851937CADENCE SIZE 1 INSERT TRIAL. 6MM
00885556851920CADENCE SIZE 5 TALAR TRIAL LEFT
00885556851913CADENCE SIZE 4 TALAR TRIAL LEFT
00885556851906CADENCE SIZE 3 TALAR TRIAL LEFT
00885556851890CADENCE SIZE 2 TALAR TRIAL LEFT
00885556851883CADENCE SIZE 1 TALAR TRIAL LEFT
00885556851876CADENCE SIZE 5 TALAR TRIAL RIGHT
00885556851869CADENCE SIZE 4 TALAR TRIAL RIGHT
00885556851852CADENCE SIZE 3 TALAR TRIAL RIGHT
00885556851845CADENCE SIZE 2 TALAR TRIAL RIGHT
00885556851838CADENCE SIZE 1 TALAR TRIAL RIGHT
00885556851821CADENCE SIZE 5 BIASED INSERT TRIAL EXTENSION
00885556851814CADENCE SIZE 4 BIASED INSERT TRIAL EXTENSION
00885556851807CADENCE SIZE 3 BIASED INSERT TRIAL EXTENSION

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