FDA UDI
In Commercial Distribution
🇺🇸 United States
Inion S-2™
DI: M224SPN55079
·
Model: 1
·
Inion Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Inion S-2™
- Primary DI
- M224SPN55079
- Version / Model
- 1
- Catalog Number
- SPN-5507
- Company Name
- Inion Oy
- Labeler DUNS
- 367994657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-07
- Public Version
- 8
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- f74b4bf1-ed72-4f99-96aa-709a03dc94e7
- Distribution End Date
- 2026-10-01
Device Description
6.7 x 31 mm screw
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
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJB | Resorbable spinal intervertebral body fixation orthosis - plate | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46650 | Spinal bone screw, bioabsorbable | A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M224SPN55079 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071810 | 000 |