FDA UDI
In Commercial Distribution
🇺🇸 United States
CoLink® NeoFuse
DI: 00810021864389
·
Model: P20 ST125
·
IN2BONES USA, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CoLink® NeoFuse
- Primary DI
- 00810021864389
- Version / Model
- P20 ST125
- Company Name
- IN2BONES USA, LLC
- Labeler DUNS
- 079700711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-21
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 35f8347f-35db-4e1e-b351-155e377ba7b2
Device Description
Anterior Fusion Plate, 5-Hole, Right
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
- 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 |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61688 | Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile | A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810021864389 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213069 | 000 |