FDA UDI
In Commercial Distribution
🇺🇸 United States
StaXx® XD System
DI: 10840642100747
·
Model: 11-1622
·
Spine Wave, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- StaXx® XD System
- Primary DI
- 10840642100747
- Version / Model
- 11-1622
- Catalog Number
- 11-1622
- Company Name
- Spine Wave, Inc.
- Labeler DUNS
- 067789763
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 4
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- 200ad212-a348-458e-9008-f01731b813ce
Device Description
Cartridge Convex Expandable Implant 22x9x15mm
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
- No
- 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 |
|---|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34170 | Vertebral body prosthesis | An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10840642100747 | GS1 |
Customer Contacts
- Phone
- 203-944-9494
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101288 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 15 | Millimeter | |
| Width | 9 | Millimeter | |
| Length | 22 | Millimeter |