AccessGUDID - DEVICE: Salto Talaris® (10381780510802)

GUDID

Device Identifier (DI) Information

Brand Name: Salto Talaris®
Version or Model: LJU990T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LJU990T
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780510802
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: Tibial Tray, XL, Size 0

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33582	Mobile-bearing total ankle prosthesis	A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is not attached or moulded to either of the components which is intended to facilitate greater joint range of motion. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182878	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do Not Use if Package is Damaged

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: XL, Size 0

Device Record Status

Public Device Record Key: 5b0271ac-6e82-4994-8925-bbf005f9ca4a
Public Version Date: January 25, 2023
Public Version Number: 2
DI Record Publish Date: January 15, 2019