AccessGUDID - DEVICE: Integra® Total Foot System" (10381780064572)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Total Foot System"
Version or Model: TARSALISIMP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TARSALISIMP
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780064572
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 Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The 2-Hole Straight Tarsalis Plate is offered in short and long lengths. The 3-Hole and 10-Hole Straight Plates are included in the system as standard lengths. The 4-Hole Straight Tarsalis Plate is offered in both standard and short lengths. The Crescentic Tarsalis Plate is offered in left and right configurations. The 4-Hole Diamond Plate is available in left and right configurations. The T-Shaped Tarsalis Plates are offered in 4-hole, 5-hole, and 6-hole configurations. The 5-hole designs are provided in straight, left, and right configurations. The 6-hole is only provided in straight configuration. Upon request, the 6-hole, 7-hole and 8-hole T-Shaped Tarsalis Plates are available.

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:	Yes
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?
61689	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile	A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, fixation, bone
HRS	PLATE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100502	000
K123000	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
No Device Sizes

Device Record Status

Public Device Record Key: cf308751-89f8-4733-937b-2149fe379eac
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: October 09, 2017