FDA UDI
In Commercial Distribution
🇺🇸 United States
PILLAR SA
DI: 18257200014286
·
Model: 49-9018
·
Orthofix US LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PILLAR SA
- Primary DI
- 18257200014286
- Version / Model
- 49-9018
- Company Name
- Orthofix US LLC
- Labeler DUNS
- 927083808
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-01
- Public Version
- 3
- Public Version Date
- 2023-02-16
- Public Version Status
- Update
- Public Device Record Key
- c119e7cd-da0f-4b00-9c9c-95d23c8cbcb8
Device Description
33mm W x 28mm D x 18mm H, 7° Lordotic Spacer
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57806 | Vertebral body prosthesis, non-sterile | A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18257200014286 | GS1 |
Customer Contacts
- Phone
- +1(214)937-3199
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 18 | Millimeter | |
| Width | 28 | Millimeter | |
| Length | 33 | Millimeter |