OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM— 510(k) K051965
Substantially EquivalentMerete Medical GmbH
FDA 510(k) clearance K051965 for OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM, Substantially Equivalent on 2006-06-16. Applicant: Merete Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Merete Medical GmbH
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oviedo, FL, US
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More 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 HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.