OSCAR BONE RESECTOR— 510(k) K083830

Substantially Equivalent

Orthosonics, Ltd.

FDA 510(k) clearance K083830 for OSCAR BONE RESECTOR, Substantially Equivalent on 2009-03-20. Applicant: Orthosonics, Ltd.. Device class: 2.

Clearance details

Applicant: Orthosonics, Ltd.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2008-12-23
Decision date: 2009-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashburton, Devon, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Orthosonics, Ltd.

K093805 — OSCAR 32010-02-19
K051053 — OSCAR, MODEL OE3000DB2005-07-21
K021502 — OSCAR, MODEL OE30002002-06-06

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