EBI DYNAFIX VS OSTEOTOMY SYSTEM— 510(k) K010551

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K010551 for EBI DYNAFIX VS OSTEOTOMY SYSTEM, Substantially Equivalent on 2001-05-17. Applicant: Ebi, L.P.. Device class: 2.

Clearance details

Applicant: Ebi, L.P.
Product code: Code NDF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2001-02-26
Decision date: 2001-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NDF

K051642 — FR.O.H. CALCANEUS REPAIR SYSTEM2005-08-22
K021749 — EBI DYNAFIX VS OSTEOTOMY SYSTEM2002-08-12

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Data sourced from openFDA. This site is unofficial and independent of the FDA.