AccessGUDID - DEVICE: Integra® TruArch® (10381780119951)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® TruArch®
Version or Model: TA1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TA1000
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780119951
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot.

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?
40352	Subtalar implant, non-bioabsorbable	A device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities; it is not intended for arthrodesis/joint fusion. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111265	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16 mm L x 10 mm dia

Device Record Status

Public Device Record Key: b5120874-8c8e-461c-bba3-648f6d5f7348
Public Version Date: February 06, 2025
Public Version Number: 6
DI Record Publish Date: October 09, 2017