FDA UDI
In Commercial Distribution
🇺🇸 United States
Valencia Pedicle Screw System
DI: B41791352201
·
Model: 913-5220
·
Altus Spine, LLC
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Valencia Pedicle Screw System
- Primary DI
- B41791352201
- Version / Model
- 913-5220
- Company Name
- Altus Spine, LLC
- Labeler DUNS
- 078331322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-28
- Public Version
- 3
- Public Version Date
- 2018-12-07
- Public Version Status
- Update
- Public Device Record Key
- 5cff5fbd-dab1-4a6f-8cd8-fb27b1e1ebd7
Device Description
5.5mm x 220mm Straight Rod
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 |
|---|---|---|---|---|
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease | Orthopedic | 888.3070 | 2 |
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | Orthopedic | 888.3060 | 2 |
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION | Orthopedic | 888.3070 | 2 |
| MNH | Orthosis, spondylolisthesis spinal fixation | Orthopedic | 888.3070 | 2 |
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | Orthopedic | 888.3050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47779 | Orthopaedic instrument surgical connector | A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B41791352201 | HIBCC | ||||
| Secondary | 00843210110677 | GS1 |
Customer Contacts
- Phone
- +1(610)355-4156
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 220 | Millimeter | |
| Outer Diameter | 5.5 | Millimeter |