Meretec CS, Cortical Screws
FDA 510(k) K130400 · Merete Medical GmbH
510(k) numberK130400
Submission
- Device name
- Meretec CS, Cortical Screws
- Applicant
- Merete Medical GmbH
Berlin, DE - Received
- February 19, 2013
- Decision date
- April 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 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 |
| K120787 | Merete Locking Bone Plate System IIIHRS · Traditional | 11/27/2012SE |
| K120978 | Osteobridge Ika Knee Arthodesis Nail with CollarHSB · Special | 05/02/2012SE |
Questions and answers
When was Meretec CS, Cortical Screws cleared by the FDA?
Meretec CS, Cortical Screws (K130400) received a 510(k) decision of Substantially Equivalent on April 5, 2013, 45 days after the submission was received.
What is the product code of K130400?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.