Medicon Stern-A-Fix Sternal Closure System
FDA 510(k) K053624 · Medicon EG
510(k) numberK053624
Submission
- Device name
- Medicon Stern-A-Fix Sternal Closure System
- Applicant
- Medicon EG
Amsterdam, Nh, NL - Received
- December 28, 2005
- Decision date
- July 17, 2006
- 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 |
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| 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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| K043297 | Medicon 2.4 Mandibular Reconstruction Plating SystemJEY · Special | 02/23/2005SE |
| K042974 | Medicon Vipair High Speed SystemHBB · Traditional | 01/13/2005SE |
| K041527 | Aarhus Anchorage SystemDZE · Traditional | 08/19/2004SE |
| K010910 | Medicon Yasargil Clip Applying ForcepsHCI · Traditional | 08/01/2001SE |
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Questions and answers
When was Medicon Stern-A-Fix Sternal Closure System cleared by the FDA?
Medicon Stern-A-Fix Sternal Closure System (K053624) received a 510(k) decision of Substantially Equivalent on July 17, 2006, 201 days after the submission was received.
What is the product code of K053624?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.