FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
K Number: K152187
·
Decision Feb 12, 2016
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
24
Review Days
191
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Basic Information
- Device Name
- MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
- K Number
- K152187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merete Medical GmbH
- Date Received
- August 5, 2015
- Decision Date
- February 12, 2016
- Product Code
- HWC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Merete Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K160548 | MC-Subtalar(TM) II | Apr 29, 2016 | Substantially Equivalent |
| K151762 | PediatrOS RigidTack/FlexTack | Dec 28, 2015 | Substantially Equivalent |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System | Feb 9, 2015 | Substantially Equivalent |
| K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD | Nov 21, 2014 | Substantially Equivalent |
| K140069 | LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 | Apr 7, 2014 | Substantially Equivalent |
| K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT | Aug 9, 2013 | Substantially Equivalent |
| K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) | May 24, 2013 | Substantially Equivalent |
| K130400 | MERETEC CS, CORTICAL SCREWS | Apr 5, 2013 | Substantially Equivalent |
| K120787 | MERETE LOCKING BONE PLATE SYSTEM III | Nov 27, 2012 | Substantially Equivalent |
| K120978 | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR | May 2, 2012 | Substantially Equivalent |