MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER— 510(k) K010701

Name: FDA 510(k) clearance K010701
Creator: U.S. Food and Drug Administration
Published: 2001-06-05

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K010701 for MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER, Substantially Equivalent on 2001-06-05. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2001-03-08
Decision date: 2001-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.