BREMER HALO SYSTEM TITANIUM SKULL PIN— 510(k) K993099

Name: FDA 510(k) clearance K993099
Creator: U.S. Food and Drug Administration
Published: 1999-12-15

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K993099 for BREMER HALO SYSTEM TITANIUM SKULL PIN, Substantially Equivalent on 1999-12-15. Applicant: Depuyacromed. Device class: 2.

Clearance details

Applicant: Depuyacromed
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1999-09-16
Decision date: 1999-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, 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.