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Latest 510(k) Clearances
Free preview of the 10 most recent FDA 510(k) decisions.
| 510(k) Number | Applicant | Device Name | Product Code | Decision Date | Decision |
|---|---|---|---|---|---|
| K261145 | Avanti Orthopaedics, LLC | Avanti Distal Elbow ORIF System | HRS | 2026-05-09 | Substantially Equivalent |
| K260385 | Carlsmed, Inc. | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | MAX | 2026-05-09 | Substantially Equivalent |
| K253679 | Stryker Instruments | Hydro Irrigation System | GWG | 2026-05-08 | Substantially Equivalent |
| K254215 | Arthrex, Inc. | Arthrex Beaming System | HWC | 2026-05-08 | Substantially Equivalent |
| K260788 | Smylio, Inc. | Smylio Aligners | NXC | 2026-05-08 | Substantially Equivalent |
| K260792 | Stabilix, LLC | AerFrame Patient Immobilization System (AFPIS) | IYE | 2026-05-08 | Substantially Equivalent |
| K250814 | Zeus Scientific | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | OBE | 2026-05-08 | Substantially Equivalent |
| K260321 | Orthopedic Driven Imaging, LLC | HipGuide (V 1.0.0.0) | LLZ | 2026-05-08 | Substantially Equivalent |
| DEN250013 | Neurovalens Limited | Modius Spero | SHX | 2026-05-08 | Unknown |
| K253237 | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | GXY | 2026-05-08 | Substantially Equivalent |
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