Mondeal Contour Ho System
FDA 510(k) K050657 · Kapp Surgical Instrument, Inc.
510(k) numberK050657
Submission
- Device name
- Mondeal Contour Ho System
- Applicant
- Kapp Surgical Instrument, Inc.
Warrensville, OH, US - Received
- March 14, 2005
- Decision date
- August 8, 2005
- 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
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| 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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| K200289 | Michler-Kapp Cardiovascular Vent CatheterDWF · Traditional | 01/28/2021SE |
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| K050384 | Kapp Bari-Ring, Model KS-BR-2005NEU · Traditional | 01/13/2006SE |
| K050655 | Mondeal Radius Ho System, Model KS-MR-2005HRS · Traditional | 08/08/2005SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | 07/28/2004SE |
| K030237 | Kapp Custom Radial Head Elbow ImplantKWI · Traditional | 08/29/2003SE |
| K844177 | Cosgrove Mitral Valve RetractorGAD · Traditional | 11/08/1984SE |
| K843368 | Kapp Spinal ButtonHTN · Traditional | 09/12/1984SE |
Questions and answers
When was Mondeal Contour Ho System cleared by the FDA?
Mondeal Contour Ho System (K050657) received a 510(k) decision of Substantially Equivalent on August 8, 2005, 147 days after the submission was received.
What is the product code of K050657?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.