LACTOSORB TRAUMA PLATING SYSTEM

Plate, Fixation, Bone

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lactosorb Trauma Plating System.

Pre-market Notification Details

Device IDK971870
510k NumberK971870
Device Name:LACTOSORB TRAUMA PLATING SYSTEM
ClassificationPlate, Fixation, Bone
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactMary Verstynen
CorrespondentMary Verstynen
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-21
Decision Date1997-08-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036073787 K971870 000
00841036067465 K971870 000

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