Merete Locking Bone Plate System III
FDA 510(k) K120787 · Merete Medical GmbH
510(k) numberK120787
Submission
- Device name
- Merete Locking Bone Plate System III
- Applicant
- Merete Medical GmbH
Rye, NY, US - Received
- March 15, 2012
- Decision date
- November 27, 2012
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K160548 | MC-Subtalar(TM) IIHWC · Traditional | 04/29/2016SE |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…HWC · Traditional | 02/12/2016SE |
| K151762 | PediatrOS RigidTack/FlexTackJDR · Traditional | 12/28/2015SE |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemHSB · Traditional | 02/09/2015SE |
| K141377 | Bioball Delta Ceramic Heads, Multicup Pe Inlay StandardLZO · Traditional | 11/21/2014SE |
| K140069 | Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS 3.0HRS · Traditional | 04/07/2014SE |
| K132226 | Metafix BLP Plate, Size 31, Left, Metafix BLP Plate, Size 31,RIGHTHRS · Special | 08/09/2013SE |
| K123619 | Intrablock Bioball Hip System (Ibs)LZO · Traditional | 05/24/2013SE |
| K130400 | Meretec CS, Cortical ScrewsHWC · Special | 04/05/2013SE |
| K120978 | Osteobridge Ika Knee Arthodesis Nail with CollarHSB · Special | 05/02/2012SE |
Questions and answers
When was Merete Locking Bone Plate System III cleared by the FDA?
Merete Locking Bone Plate System III (K120787) received a 510(k) decision of Substantially Equivalent on November 27, 2012, 257 days after the submission was received.
What is the product code of K120787?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.