FDA UDI
In Commercial Distribution
🇺🇸 United States
FibFix
DI: 00840124517486
·
Model: FN-TH-9200-S
·
FUSION ORTHOPEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FibFix
- Primary DI
- 00840124517486
- Version / Model
- FN-TH-9200-S
- Catalog Number
- FN-TH-9200-S
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-08
- Public Version
- 1
- Public Version Date
- 2026-04-16
- Public Version Status
- New
- Public Device Record Key
- ab02e036-d6c1-469e-a1e8-15810d3484d9
Device Description
End Cap Threaded 7.4mm x 20mm (Sterile)
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDT | Cap, Bone | Orthopedic | 888.3000 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46139 | Bone nail implantable cap | A small, implantable, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. Commonly known as an end-cap, it is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840124517486 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252961 | 000 |