PathLoc- SI Joint Fusion System
- Primary DI
- 08800061394177
- Brand
- PathLoc- SI Joint Fusion System
- Company
- L&K BIOMED CO. ,LTD.
- Model
- 1025-7065S
- Catalog number
- 1025-7065S
- Device description
- Locking Screw
- Published
- 2023-07-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| OUR | Sacroiliac Joint Fixation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OUR | Sacroiliac Joint Fixation | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K231841 | 000 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2023-07-14 | OUR |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08800061394177 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08800061394177 | 08800061394177 | 8800061394177 |
GMDN Terms
| Term | Definition |
|---|
| Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated | An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments. |
Regulatory Flags
- DUNS number
- 631159324
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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