FDA UDI
In Commercial Distribution
🇺🇸 United States
PolyLock Midfoot
DI: 00840124521889
·
Model: TN-CA-7003
·
FUSION ORTHOPEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PolyLock Midfoot
- Primary DI
- 00840124521889
- Version / Model
- TN-CA-7003
- Catalog Number
- TN-CA-7003
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-02
- Public Version
- 1
- Public Version Date
- 2025-10-10
- Public Version Status
- New
- Public Device Record Key
- 70731341-0612-49aa-8650-bd308d2a4664
Device Description
Calcaneus Spreader
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCJ | Tissue Expander And Accessories | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45533 | Horizontal non-powered traction system | An assembly of devices designed to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae by means of attached harnesses whilst the patient typically lies in a supine position on the table during treatment. The assembly usually consists of several specialized harnesses, a combination of pulleys and cords, and a set of weights that hang from the cords as the source of the traction force (the patient's own weight or pneumatic devices may also be used). Adjustable spreader bars may be used to vary the angle at which the cord applies the traction. The assembly is used in orthopaedic and/or physical therapy procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840124521889 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211843 | 000 |