LINK™ External Fixator
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Basic Information
- Brand Name
- LINK™ External Fixator
- Primary DI
- M96320TT0
- Version / Model
- 20TT
- Catalog Number
- 20TT
- Company Name
- METRIC MEDICAL DEVICES, INC.
- Labeler DUNS
- 830255506
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-07
- Public Version
- 1
- Public Version Date
- 2024-06-17
- Public Version Status
- New
- Public Device Record Key
- d0a33858-9f3c-42c0-8074-97a07daea0e1
Device Description
2.0 mm Diameter, Threaded Bone Pins as part of the LINK™ External Fixator, provided in a segregate package to allow for control of the amount of pins used per procedure. The LINK™ External Fixator is indicated for use in the treatment of bone conditions including osteotomy, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. The LINK™ External Fixation System components are not intended to replace normal healthy bone or to withstand the stresses of full weightbearing, particularly in unstable fractures or in the presence of non-union, delayed union or incomplete healing. The use of external supports (e.g. walking aids) is recommended as a part of the treatment.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48011 | External orthopaedic fixation system, single-use | An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M96320TT0 | HIBCC |
Customer Contacts
- Phone
- 8305356300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240049 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.0 | Millimeter | |
| Length | 6 | Inch |