LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0— 510(k) K140069
Substantially EquivalentMerete Medical GmbH
FDA 510(k) clearance K140069 for LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0, Substantially Equivalent on 2014-04-07. Applicant: Merete Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Merete Medical GmbH
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berlin, DE
Recent devices under product code HRS
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- K152187 — MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
- K151762 — PediatrOS RigidTack/FlexTack
- K142451 — OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
- K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.