CastleLoc Pectus Bar System
FDA 510(k) K243357 · L&K BIOMED Co., Ltd.
510(k) numberK243357
Submission
- Device name
- CastleLoc Pectus Bar System
- Applicant
- L&K BIOMED Co., Ltd.
Yongin-Si, KR - Received
- October 29, 2024
- Decision date
- February 27, 2025
- 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 |
|---|---|---|
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | 08/18/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | 05/16/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | 05/06/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | 05/05/2026SE |
| K260448 | CastleLoc Pectus Bar SystemHRS · Special | 03/19/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | 03/03/2026SE |
| K251741 | PathLoc Lumbar Interbody Fusion Cage SystemMAX · Special | 07/08/2025SE |
| K250892 | CastleLoc Pectus Bar SystemHRS · Special | 04/25/2025SE |
| K242829 | BluEX Lumbar Expandable Cage SystemMAX · Traditional | 10/23/2024SE |
| K240201 | PathLoc SI Joint Fusion SystemOUR · Special | 02/23/2024SE |
Questions and answers
When was CastleLoc Pectus Bar System cleared by the FDA?
CastleLoc Pectus Bar System (K243357) received a 510(k) decision of Substantially Equivalent on February 27, 2025, 121 days after the submission was received.
What is the product code of K243357?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.