MAXMORESPINE SPINAL SYSTEM

Arthroscope

HOOGLAND SPINE PRODUCTS GMBH

The following data is part of a premarket notification filed by Hoogland Spine Products Gmbh with the FDA for Maxmorespine Spinal System.

Pre-market Notification Details

Device IDK090132
510k NumberK090132
Device Name:MAXMORESPINE SPINAL SYSTEM
ClassificationArthroscope
Applicant HOOGLAND SPINE PRODUCTS GMBH ARABELLASTR 4 Muenchen,  DE D-81925
ContactBoris Miklitz
CorrespondentBoris Miklitz
HOOGLAND SPINE PRODUCTS GMBH ARABELLASTR 4 Muenchen,  DE D-81925
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-21
Decision Date2009-06-09
Summary:summary

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