MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM— 510(k) K050457
Substantially EquivalentMerete Medical GmbH
FDA 510(k) clearance K050457 for MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM, Substantially Equivalent on 2005-03-14. Applicant: Merete Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Merete Medical GmbH
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code KTT
view allMore clearances from Merete Medical GmbH
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
- K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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.