FDA UDI
In Commercial Distribution
🇺🇸 United States
ALEUTIAN® Interbody Systems
DI: 10888857134218
·
Model: 703-22136L15
·
K2M, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ALEUTIAN® Interbody Systems
- Primary DI
- 10888857134218
- Version / Model
- 703-22136L15
- Catalog Number
- 703-22136L15
- Company Name
- K2M, INC.
- Labeler DUNS
- 146060863
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-07
- Public Version
- 2
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 6b0808f2-efb8-4ec7-8dd7-42bfed597f4a
Device Description
Lordotic Implant, Size 28x36x21 mm, 15 Deg.
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
- 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 |
|---|---|---|---|---|
| MAX | Intervertebral fusion device with bone graft, lumbar | Orthopedic | 888.3080 | 2 |
| MQP | Spinal vertebral body replacement device | Orthopedic | 888.3060 | 2 |
| ODP | Intervertebral fusion device with bone graft, cervical | Orthopedic | 888.3080 | 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 | 10888857134218 | GS1 |
Customer Contacts
- Phone
- +1(571)919-2000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110843 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 15 | degree | |
| Width | 36 | Millimeter | |
| Height | 21 | Millimeter | |
| Length | 28 | Millimeter |