Cadence Total Ankle System 10209537

GUDID 00885556854549

CADENCE INSERT. SIZE 5 LEFT 7MM ANTERIOR-BIASED

Smith & Nephew, Inc.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00885556854549
• NIH Device Record Key: cfda0f45-d47f-4e41-83bd-16c234e9c9f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadence Total Ankle System
• Version Model Number: 10209537
• Catalog Number: 10209537
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556854549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151459

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-22

On-Brand Devices [Cadence Total Ankle System]

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