FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NEXIS
DI: 03700879508481
·
Model: TS020026
·
NOVASTEP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NEXIS
- Primary DI
- 03700879508481
- Version / Model
- TS020026
- Catalog Number
- TS020026
- Company Name
- NOVASTEP
- Labeler DUNS
- 264255288
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-31
- Public Version
- 6
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- e9088536-e3ff-4870-bc30-ce73b22fcb9d
- Distribution End Date
- 2022-06-29
Device Description
NEXIS Screw Ø2.9 Fully Threaded length 26
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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47875 | Bone-nailing compression screw | A rod-like orthopaedic surgical instrument designed to be inserted (screwed) through the insertion handle of an orthopaedic implant aiming arm to impart a force upon a proximally inserted bone nail locking screw thus creating compression on the proximal section of a fractured bone to close the fracture gap with the distal section which can then be locked into final position. It is typically made of high-grade stainless steel and has a threaded portion at the proximal end together with a head for acceptance of a screwdriver or other tool to provide the necessary rotation. It is available in a variety of lengths and is usually used when nailing the tibia or humerus. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700879508481 | GS1 |
Customer Contacts
- Phone
- +33299338650
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143229 | 000 |