FDA UDI
In Commercial Distribution
🇺🇸 United States
VIA Spinous Process Fixation System
DI: M7404400004
·
Model: 34-01-04
·
SPINEOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- VIA Spinous Process Fixation System
- Primary DI
- M7404400004
- Version / Model
- 34-01-04
- Catalog Number
- 440-0004
- Company Name
- SPINEOLOGY INC.
- Labeler DUNS
- 033014361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-09
- Public Version
- 5
- Public Version Date
- 2024-07-23
- Public Version Status
- Update
- Public Device Record Key
- b3210c60-90ca-4217-8964-41c429e4dee4
Device Description
Male Plate
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PEK | Spinous process plate | Orthopedic | 888.3050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61533 | Interspinous spinal fixation implant | An implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7404400004 | HIBCC |
Customer Contacts
- Phone
- +1(651)256-8500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142213 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 15x39 | ||
| Height | 15 | Millimeter |