FDA UDI
In Commercial Distribution
🇺🇸 United States
ProMIS™ Fixation System
DI: 07290115933635
·
Model: 87680
·
PREMIA SPINE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ProMIS™ Fixation System
- Primary DI
- 07290115933635
- Version / Model
- 87680
- Company Name
- PREMIA SPINE LTD
- Labeler DUNS
- 649220779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-17
- Public Version
- 1
- Public Version Date
- 2024-01-25
- Public Version Status
- New
- Public Device Record Key
- fc0aebe8-4ebe-49ca-ac85-a94869dff60d
Device Description
Straight Rod Ø6.0x220mm Hex Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
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
- 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 |
|---|---|---|---|---|
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61325 | Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290115933635 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231844 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 220 | Millimeter | |
| Outer Diameter | 6 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 22 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 70 Percent (%) Relative Humidity