FDA UDI
In Commercial Distribution
🇺🇸 United States
FS3 Facet Screw Spinal System
DI: 00190837041137
·
Model: 116-409
·
Life Spine, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FS3 Facet Screw Spinal System
- Primary DI
- 00190837041137
- Version / Model
- 116-409
- Catalog Number
- 116-409
- Company Name
- Life Spine, Inc.
- Labeler DUNS
- 183641617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-07
- Public Version
- 2
- Public Version Date
- 2024-08-30
- Public Version Status
- Update
- Public Device Record Key
- 5f7bc8dd-e7b2-4fea-b596-6ad97105662b
Device Description
K-Wire Installer
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| MRW | SYSTEM, FACET SCREW SPINAL DEVICE | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66934 | Orthopaedic intraoperative positioning pin, reusable | A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190837041137 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090865 | 000 |