Stratum Reduced Size Foot Plating System
FDA 510(k) K200785 · Nextremity Solutions, Inc.
510(k) numberK200785
Submission
- Device name
- Stratum Reduced Size Foot Plating System
- Applicant
- Nextremity Solutions, Inc.
Warsaw, IN, US - Received
- March 26, 2020
- Decision date
- July 27, 2020
- 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 |
|---|---|---|
| K221610 | Nextra CH Cannulated Hammertoe SystemHWC · Traditional | 11/04/2022SE |
| K212979 | CalcShift Displacement Calcaneal Osteotomy SystemHRS · Traditional | 05/20/2022SE |
| K220181 | StealthFix Intraosseous Fixation SystemJDR · Traditional | 03/22/2022SE |
| K213301 | InCore Subtalar SystemHWC · Traditional | 12/21/2021SE |
| K213530 | Nextra CH Cannulated Hammertoe SystemHWC · Special | 12/09/2021SE |
| K212640 | Stratum® Ankle Fusion Plating SystemHRS · Traditional | 11/18/2021SE |
| K211996 | Nexta PEEK Hammertoe Correction SystemHWC · Traditional | 09/23/2021SE |
| K200840 | DuoHex CH Cannulated Hammertoe SystemHWC · Traditional | 06/26/2020SE |
| K200124 | InCore MPJ SystemHWC · Traditional | 05/13/2020SE |
| K192578 | InCore TMT SystemHWC · Traditional | 12/31/2019SE |
Questions and answers
When was Stratum Reduced Size Foot Plating System cleared by the FDA?
Stratum Reduced Size Foot Plating System (K200785) received a 510(k) decision of Substantially Equivalent on July 27, 2020, 123 days after the submission was received.
What is the product code of K200785?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.