SOLCO 4CIS® General Plate System
- Primary DI
- 08806373530562
- Brand
- SOLCO 4CIS® General Plate System
- Company
- ALPHA AI CO.,LTD.
- Model
- 63-20610
- Catalog number
- 63-20610
- Device description
- Narrow self compression plates
- Published
- 2026-04-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HRS | Plate, Fixation, Bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K051155 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08806373530562 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08806373530562 | 08806373530562 | 8806373530562 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 687844241
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08800377762103 | Spinal Fusion Cage System | DPUC-40J8 | DPUC-40J8 | 2024-02-22 |
| 08800377762127 | Spinal Fusion Cage System | DPUC-40JA | DPUC-40JA | 2024-02-22 |
| 08800377762141 | Spinal Fusion Cage System | DPUC-40JC | DPUC-40JC | 2024-02-22 |
| 08800377762165 | Spinal Fusion Cage System | DPUC-40JE | DPUC-40JE | 2024-02-22 |
| 08800377762363 | Spinal Fusion Cage System | DPUC-45J8 | DPUC-45J8 | 2024-02-22 |
| 08800377762387 | Spinal Fusion Cage System | DPUC-45JA | DPUC-45JA | 2024-02-22 |
| 08800377762400 | Spinal Fusion Cage System | DPUC-45JC | DPUC-45JC | 2024-02-22 |
| 08800377762424 | Spinal Fusion Cage System | DPUC-45JE | DPUC-45JE | 2024-02-22 |
| 08800377762622 | Spinal Fusion Cage System | DPUC-50J8 | DPUC-50J8 | 2024-02-22 |
| 08800377762646 | Spinal Fusion Cage System | DPUC-50JA | DPUC-50JA | 2024-02-22 |
| 08800377762660 | Spinal Fusion Cage System | DPUC-50JC | DPUC-50JC | 2024-02-22 |
| 08800377762684 | Spinal Fusion Cage System | DPUC-50JE | DPUC-50JE | 2024-02-22 |
| 08800377762882 | Spinal Fusion Cage System | DPUC-55J8 | DPUC-55J8 | 2024-02-22 |
| 08800377762905 | Spinal Fusion Cage System | DPUC-55JA | DPUC-55JA | 2024-02-22 |
| 08800377762929 | Spinal Fusion Cage System | DPUC-55JC | DPUC-55JC | 2024-02-22 |
| 08800377762943 | Spinal Fusion Cage System | DPUC-55JE | DPUC-55JE | 2024-02-22 |
| 08800313887983 | SOLCO 4CIS® General Plate System | 96-50810 | 96-50810 | 2026-04-21 |
| 08800313887044 | 4CIS® Spinal System and 4CIS® Low Back System | 62-45045 | 62-45045 | 2026-04-15 |
| 08800313887051 | 4CIS® Spinal System and 4CIS® Low Back System | 62-55050 | 62-55050 | 2026-04-15 |
| 08800313887068 | 4CIS® Spinal System and 4CIS® Low Back System | 62-65030 | 62-65030 | 2026-04-15 |
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