FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT— 510(k) K981194

Name: FDA 510(k) clearance K981194
Creator: U.S. Food and Drug Administration
Published: 1998-06-30

Substantially Equivalent

Nexa Orthopedics, Inc.

FDA 510(k) clearance K981194 for FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT, Substantially Equivalent on 1998-06-30. Applicant: Nexa Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Nexa Orthopedics, Inc.
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1998-04-02
Decision date: 1998-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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