AccessGUDID - DEVICE: Integra® Total Wrist Fusion System (10381780064350)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Total Wrist Fusion System
Version or Model: WRISTFUSESET
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: WRISTFUSESET
Company Name: INTEGRA LIFESCIENCES CORPORATION

Primary DI Number: 10381780064350
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 963856096 *Terms of Use

Device Description: The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nine holes. These plates are fixed to the bone with 2.7mm diameter and 3.5mm diameter screws. Instrumentation is provided to assist in the implantation. Screws with a diameter of 2.7mm vary in size length from 10mm to 24mm. Screws with a diameter of 3.5mm vary in size length from 12mm to 28mm. This system is generally indicated for use in patients with arthritis of the joints of the wrist, rheumatoid wrist deformities, carpal instability, wrist pain, brachial plexus nerve palsies, and loss of function due to osteoarthritis.

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:	No
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?
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
HRS	Plate, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 20.10 in L x 10.84 in W

Device Record Status

Public Device Record Key: 0ed23ab1-376b-4244-b23b-4e8602d40956
Public Version Date: September 11, 2024
Public Version Number: 6
DI Record Publish Date: August 15, 2015