Salto Talaris® LJU200T

GUDID 10381780365075

Talar Dome, Size 0, Right

Ascension Orthopedics, Inc.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 10381780365075
• NIH Device Record Key: 28eb3303-6977-4d76-aef3-979108937dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salto Talaris®
• Version Model Number: LJU200T
• Catalog Number: LJU200T
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700386926488 [Previous]
GS1	10381780365075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130533

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: 5
• Public Version Date: 2021-03-29
• Device Publish Date: 2017-04-25

On-Brand Devices [Salto Talaris®]

• 10381780510949: Tibial Implant Extractor
• 10381780510901: Insert Extractor
• 10381780511182: Total Ankle Prosthesis Reamer, 3 mm X 140 mm
• 10381780510994: Total Ankle Prosthesis Drill Bit, 3 mm Dia. X 135 mm
• 10381780510987: Total Ankle Prosthesis Self-Drilling Pin, 3 x 110
• 10381780510970: Total Ankle Prosthesis Self-Drilling Pin
• 10381780510963: Total Ankle Prosthesis Self-Drilling Pin
• 10381780510956: Total Ankle Prosthesis Set of 12 pins + 1 reamer
• 10381780368311: Drill Guide, Bell Saw, Size 0
• 10381780374107: Integra XT, Revision Instrument Tray 2
• 10381780374091: Integra XT, Revision Instrument Tray 1
• 10381780374084: Integra XT, Revision Instrument Case 2
• 10381780374053: Salto Talaris, Caddy
• 10381780374046: Salto Talaris, Primary Instrument Tray 2
• 10381780374039: Salto Talaris, Primary Instrument Tray 1
• 10381780374022: Salto Talaris, Primary Instrument Case 2
• 10381780374015: Salto Talaris, Primary Instrument Case 1
• 10381780369059: Tray, Extended PE Trial Insert
• 10381780369042: YKAL55 Trial Insert Caddy, 00-0-01
• 10381780369035: YKAL55 Trial Insert Caddy, 00-0-01
• 10381780369028: YKAL54 base
• 10381780369011: YKAL54 Superior Tray
• 10381780369004: YKAL54 Inferior Tray
• 10381780368991: YKAL14 Superior Tray
• 10381780368984: YKAL14 Inferior Tray
• 10381780368977: YKAL13 Base
• 10381780368960: YKAL11 Insert
• 10381780368953: YKAL11 Base
• 10381780366287: Talar Dome, Flat Cut, Size 3, Left
• 10381780366270: Talar Dome, Flat Cut, Size 2, Left
• 10381780366263: Talar Dome, Flat Cut, Size 1, Left
• 10381780366256: Talar Dome, Flat Cut, Size 3, Right
• 10381780366249: Talar Dome, Flat Cut, Size 2, Right
• 10381780366232: Talar Dome, Flat Cut, Size 1, Right
• 10381780365143: Talar Dome, Size 3, Left
• 10381780365136: Talar Dome, Size 2, Left
• 10381780365129: Talar Dome, Size 1, Left
• 10381780365112: Talar Dome, Size 0, Left
• 10381780365105: Talar Dome, Size 3, Right
• 10381780365099: Talar Dome, Size 2, Right
• 10381780365082: Talar Dome, Size 1, Right
• 10381780365075: Talar Dome, Size 0, Right
• 10381780365068: Tibial Tray, Size 3
• 10381780365051: Tibial Tray, Size 2
• 10381780365044: Tibial Tray, Size 1
• 10381780365037: Tibial Tray, Size 0
• 10381780369073: Set of 11 Pins + 1 Reamer
• 10381780366812: Pin, 3 mm x 45 mm
• 10381780510932: Fixation Plug, Size 0
• 10381780510925: Insert Assembly Bench Press