Anatomic Bone Plate
FDA 510(k) K221088 · Double Medical Technology, Inc.
510(k) numberK221088
Submission
- Device name
- Anatomic Bone Plate
- Applicant
- Double Medical Technology, Inc.
Xiamen, CN - Received
- April 13, 2022
- Decision date
- January 18, 2023
- 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 |
|---|---|---|
| K252729 | Universal Spinal SystemNKB · Traditional | 11/18/2025SE |
| K242348 | Locking Screw,CoCrMoHWC · Abbreviated | 12/04/2024SE |
| K233078 | Posterior Cervical Spine SystemNKG · Traditional | 11/22/2023SE |
| K223753 | Cervical Plate SystemKWQ · Traditional | 03/14/2023SE |
| K221150 | Advanced Bone PlateHRS · Traditional | 01/25/2023SE |
| K221090 | Metal Cannulated ScrewHWC · Traditional | 01/10/2023SE |
| K221221 | Advanced Intramedullary Nail SystemHSB · Traditional | 12/21/2022SE |
| K220921 | Metal Bone ScrewHWC · Traditional | 12/12/2022SE |
| K172830 | Double Medical Femoral Nail SystemHSB · Traditional | 08/24/2018SE |
| K172828 | Double Medical Cage SystemMAX · Traditional | 02/01/2018SE |
Questions and answers
When was Anatomic Bone Plate cleared by the FDA?
Anatomic Bone Plate (K221088) received a 510(k) decision of Substantially Equivalent on January 18, 2023, 280 days after the submission was received.
What is the product code of K221088?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.