LINK™ External Fixator
Basic Information
- Brand Name
- LINK™ External Fixator
- Primary DI
- M96322000200
- Version / Model
- 2-200020
- Catalog Number
- 2-200020
- 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
- d33d0620-c13f-445e-9888-2a7c9cfc16a1
Device Description
LINK™ External Fixator, 2 Pin, Straight Configuration intended for assembly and use with appropriately sized Bone Pins designed to stabilize fractured bones, osteotomies, or arthrodesis to promote treatment and healing. This is a single-use device that is provided sterile. A silicone cover is provided within the package to assist with the protection of the LINK™ structure. 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 | M96322000200 | HIBCC |
Customer Contacts
- Phone
- 830.535.6300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240049 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 Pin, Linear, Pin Hole to Pin Hole 20mm in Length |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 76.7 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 170 Degrees Fahrenheit