MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599— 510(k) K061089

Name: FDA 510(k) clearance K061089
Creator: U.S. Food and Drug Administration
Published: 2006-06-20

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K061089 for MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599, Substantially Equivalent on 2006-06-20. Applicant: Biopro, Inc.. Device class: 2.

Clearance details

Applicant: Biopro, Inc.
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2006-04-18
Decision date: 2006-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, 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.