FDA UDI
In Commercial Distribution
🇺🇸 United States
CREO
DI: 00889095124668
·
Model: 5119.8830
·
GLOBUS MEDICAL, INC.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CREO
- Primary DI
- 00889095124668
- Version / Model
- 5119.8830
- Company Name
- GLOBUS MEDICAL, INC.
- Labeler DUNS
- 139105691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-14
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 064103ec-c3dd-4460-8dd3-25b5ddcb716c
Device Description
CREO® 5.5, 8.5 x 30mm Uniplanar Fracture Screw
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis | 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 |
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37272 | Trans-facet-screw internal spinal fixation system, sterile | A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889095124668 | GS1 |
Customer Contacts
- Phone
- +1(610)930-1800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K124058 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Millimeter | |
| Outer Diameter | 8.5 | Millimeter |