FDA UDI
In Commercial Distribution
🇺🇸 United States
Mont Blanc Spinal Systems
DI: 03663422002280
·
Model: 1
·
SPINEWAY
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Mont Blanc Spinal Systems
- Primary DI
- 03663422002280
- Version / Model
- 1
- Catalog Number
- MB1RC55500
- Company Name
- SPINEWAY
- Labeler DUNS
- 281075270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2017-03-16
- Public Version
- 5
- Public Version Date
- 2025-07-02
- Public Version Status
- Update
- Public Device Record Key
- f80a6269-90da-44a9-a628-b160a3fbeda8
Device Description
ROD Ø:5.5 L:500mm, cobalt chrome
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 |
|---|---|---|---|---|
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Orthopedic | 888.3070 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | 888.3050 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | 888.3070 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | 888.3070 | 2 |
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03663422002280 | GS1 | ||||
| Unit of Use | 13663422002287 | GS1 |
Customer Contacts
- Phone
- +33472770152
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161387 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 500 | Millimeter | |
| Outer Diameter | 5.5 | Millimeter |