FDA UDI
In Commercial Distribution
🇺🇸 United States
FuzeFix Max FT
DI: 00840124523951
·
Model: FX-SC-3045
·
FUSION ORTHOPEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FuzeFix Max FT
- Primary DI
- 00840124523951
- Version / Model
- FX-SC-3045
- Catalog Number
- FX-SC-3045
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-22
- Public Version
- 2
- Public Version Date
- 2025-11-13
- Public Version Status
- Update
- Public Device Record Key
- 3dc6b2ec-8ec2-42b7-b14f-b02f70c8c8b4
Device Description
Static Nail 3.0mm x 45mm
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
- 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
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66847 | Human chorionic gonadotropin beta-subunit IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) in a clinical specimen, using a fluorescent immunoassay method. It is typically used for early detection of pregnancy, as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage), or as an indicator of trisomy 21 (Down syndrome) during pregnancy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840124523951 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170038 | 000 |