FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Total Wrist Fusion System
DI: 10381780064350
·
Model: WRISTFUSESET
·
INTEGRA LIFESCIENCES CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® Total Wrist Fusion System
- Primary DI
- 10381780064350
- Version / Model
- WRISTFUSESET
- Catalog Number
- WRISTFUSESET
- Company Name
- INTEGRA LIFESCIENCES CORPORATION
- Labeler DUNS
- 963856096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-15
- Public Version
- 4
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 0ed23ab1-376b-4244-b23b-4e8602d40956
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Orthopedic | 888.3030 | 2 |
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M268WRISTFUSESET0 | HIBCC | ||||
| Primary | 10381780064350 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093163 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20.10 in L x 10.84 in W |