AGILITY 140403050

GUDID 10603295035299

AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 3 LEFT CEMENTED

DEPUY ORTHOPAEDICS, INC.

Coated ankle talus prosthesis

• Primary Device ID: 10603295035299
• NIH Device Record Key: b748574b-3de7-4e8e-8289-d699730e1ecb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AGILITY
• Version Model Number: 1404-03-050
• Catalog Number: 140403050
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295035299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053569

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: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2015-09-24

On-Brand Devices [AGILITY]

• 10603295142645: AGILITY QR DRILL BIT 3.2mm x 89mm
• 10603295122388: AGILITY LP POLY TRIAL SIZE 6/5
• 10603295122371: AGILITY LP +1 POLY TRIAL SIZE 6
• 10603295122364: AGILITY LP POLY TRIAL SIZE 6
• 10603295122340: AGILITY LP POLY TRIAL SIZE 5/4
• 10603295122333: AGILITY LP +1 POLY TRIAL SIZE 5
• 10603295122326: AGILITY LP POLY TRIAL SIZE 5
• 10603295122296: AGILITY LP POLY TRIAL SIZE 4/3
• 10603295122289: AGILITY LP +1 POLY TRIAL SIZE 4
• 10603295122272: AGILITY LP POLY TRIAL SIZE 4
• 10603295122258: AGILITY LP POLY TRIAL SIZE 3/2
• 10603295122241: AGILITY LP +1 POLY TRIAL SIZE 3
• 10603295122234: AGILITY LP TIB INSERT TRIAL SIZE 3
• 10603295122210: AGILITY LP POLY TRIAL SIZE 2/1
• 10603295122203: AGILITY LP +1 POLY TRIAL SIZE 2
• 10603295122197: AGILITY LP TIB INSERT TRIAL SIZE 2
• 10603295122180: AGILITY LP +1 POLY TRIAL SIZE 1
• 10603295122173: AGILITY LP TIB INSERT TRIAL SIZE 1
• 10603295142614: AGILITY LP BURR FIXATION PIN 2/PK NON-THREAD
• 10603295058625: AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 6 CEMENTED
• 10603295058618: AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 5 CEMENTED
• 10603295058601: AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 4 CEMENTED
• 10603295058595: AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 3 CEMENTED
• 10603295058588: AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 2 CEMENTED
• 10603295058571: AGILITY TOTAL ANKLE SYSTEM REVISION TALAR SIZE 1 CEMENTED
• 10603295035473: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 6 LEFT CEMENTED
• 10603295035442: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 6 RIGHT CEMENTED
• 10603295035411: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 5 LEFT CEMENTED
• 10603295035381: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 5 RIGHT CEMENTED
• 10603295035350: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 4 LEFT CEMENTED
• 10603295035329: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 4 RIGHT CEMENTED
• 10603295035299: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 3 LEFT CEMENTED
• 10603295035268: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 3 RIGHT CEMENTED
• 10603295035237: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 2 LEFT CEMENTED
• 10603295035206: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 2 RIGHT CEMENTED
• 10603295035176: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 1 LEFT CEMENTED
• 10603295035145: AGILITY LP TOTAL ANKLE SYSTEM TALAR SIZE 1 RIGHT CEMENTED
• 10603295142522: AGILITY POLY REV NO COLUMN SIZE 6
• 10603295142515: AGILITY TIBIAL INSERT TRIAL SIZE 6 +2
• 10603295142508: AGILITY POLY REG NO COLUMN SIZE 6
• 10603295142485: AGILITY POLY REV NO COLUMN SIZE 5
• 10603295142461: AGILITY POLY REG NO COLUMN SIZE 5
• 10603295142447: AGILITY POLY REV NO COLUMN SIZE 4
• 10603295142423: AGILITY POLY REG NO COLUMN SIZE 4
• 10603295142409: AGILITY POLY REV NO COLUMN SIZE 3
• 10603295142386: AGILITY POLY REG NO COLUMN SIZE 3
• 10603295142379: AGILITY TIBIAL INSERT TRIAL SIZE 3
• 10603295142362: AGILITY POLY REV NO COLUMN SIZE 2
• 10603295142348: AGILITY POLY REG NO COLUMN SIZE 2
• 10603295142324: AGILITY POLY REV NO COLUMN SIZE 1