FDA 510(k) ClearanceHRS
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
FDA 510(k) K253916 · Medartis AG
Clearance details
Ask AI- 510(k) number
- K253916
- Device name
- APTUS Shoulder Proximal Humerus System, PentaLock 3.5
- Applicant
- Medartis AG
- Product code
- HRS
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 888.3030
- Advisory committee
- OR
- Medical specialty
- Orthopedic
Candidate predicate devices
Ask AIOther devices cleared under product code HRS form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | |
| K262649 | Alians Forearm | Newclip Technics | |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | |
| K261511 | Xpert Ankle | Newclip Technics | |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. |
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