Solco 4CIS General Plate System
FDA 510(k) K051155 · Solco Biomedical Co., Ltd.
510(k) numberK051155
Submission
- Device name
- Solco 4CIS General Plate System
- Applicant
- Solco Biomedical Co., Ltd.
Bethesda, MD, US - Received
- May 4, 2005
- Decision date
- July 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K231655 | 4CIS® Chiron Spinal Fixation SystemNKB · Special | 11/26/2024SE |
| K203233 | 4CIS Chiron Spinal Fixation SystemNKB · Special | 06/01/2022SE |
| K192044 | 4CIS Marlin PEEK ACIF CageODP · Traditional | 12/19/2019SE |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…MAX · Traditional | 09/18/2019SE |
| K190471 | 4CIS® Chiron Spinal Fixation SystemNKB · Traditional | 07/24/2019SE |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate systemKWQ · Traditional | 01/16/2019SE |
| K162402 | 4CIS® Marlin ACIF Cage SystemODP · Traditional | 02/16/2017SE |
| K121615 | 4CIS Vane Spine SystemMNI · Special | 08/15/2012SE |
| K102458 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemMNH · Special | 06/13/2011SE |
| K101818 | 4CIS Vane Spine SystemMNH · Traditional | 02/11/2011SE |
Questions and answers
When was Solco 4CIS General Plate System cleared by the FDA?
Solco 4CIS General Plate System (K051155) received a 510(k) decision of Substantially Equivalent on July 11, 2005, 68 days after the submission was received.
What is the product code of K051155?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.