BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD— 510(k) K141377
Substantially EquivalentMerete Medical GmbH
FDA 510(k) clearance K141377 for BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD, Substantially Equivalent on 2014-11-21. Applicant: Merete Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Merete Medical GmbH
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berlin, DE
Recent devices under product code LZO
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view all- K160548 — MC-Subtalar(TM) II
- 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
- K140069 — LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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.