FDA UDI
In Commercial Distribution
🇺🇸 United States
LumFix Spinal Fixation System
DI: 08809658602039
·
Model: CRODST55500
·
CG Bio Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LumFix Spinal Fixation System
- Primary DI
- 08809658602039
- Version / Model
- CRODST55500
- Company Name
- CG Bio Co., Ltd.
- Labeler DUNS
- 631130655
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-17
- Public Version
- 2
- Public Version Date
- 2020-07-29
- Public Version Status
- Update
- Public Device Record Key
- c2be78cb-170a-4749-88cd-73b2b1a709bf
Device Description
Regulation Name: Pedicle screw spinal system
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
- 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 |
|---|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | 888.3070 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61325 | Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809658602039 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160731 | 000 |