Variax 2 Compression Plating System
FDA 510(k) K140565 · Stryker Trauma AG
510(k) numberK140565
Submission
- Device name
- Variax 2 Compression Plating System
- Applicant
- Stryker Trauma AG
Mahwah, NJ, US - Received
- March 5, 2014
- Decision date
- May 29, 2014
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K200869 | Gamma3 SystemHSB · Traditional | 07/22/2020SE |
| K193308 | T2 Alpha Tibia Nailing System, IMN Screws SystemHSB · Traditional | 02/23/2020SE |
| K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…HSB · Special | 06/11/2019SE |
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…HSB · Traditional | 06/06/2018SE |
| K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB · Traditional | 01/12/2018SE |
| K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | 10/02/2017SE |
| K170418 | Stryker SonicPin SystemHTY · Traditional | 06/20/2017SE |
| K153154 | Asnis JFX SystemHWC · Traditional | 12/28/2015SE |
| K151178 | VariAx 2 Wrist Fusion SystemHRS · Traditional | 06/24/2015SE |
| K143063 | Stryker SonicPin System, Stryker SonicAnchor SystemHTY · Traditional | 01/27/2015SE |
Questions and answers
When was Variax 2 Compression Plating System cleared by the FDA?
Variax 2 Compression Plating System (K140565) received a 510(k) decision of Substantially Equivalent on May 29, 2014, 85 days after the submission was received.
What is the product code of K140565?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.