FDA UDI
In Commercial Distribution
🇺🇸 United States
SternaFuse® Fixation System
DI: 00810047770039
·
Model: 76-3016-2
·
Fusion Innovations LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SternaFuse® Fixation System
- Primary DI
- 00810047770039
- Version / Model
- 76-3016-2
- Company Name
- Fusion Innovations LLC
- Labeler DUNS
- 024495683
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-14
- Public Version
- 1
- Public Version Date
- 2022-12-22
- Public Version Status
- New
- Public Device Record Key
- 83938956-44a7-4e6d-9fd2-2692f4996e6d
Device Description
Locking Screw 2-Pack Ø3.0mm X 16mm, Cancellous, Self-Drilling
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34017 | Sternal fixation device | A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810047770039 | GS1 |
Customer Contacts
- Phone
- 1-888-316-7627
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202914 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 16 | Millimeter | |
| Outer Diameter | 3.0 | Millimeter |