LACTOSORB SHEETS

Plate, Bone

BIOMET, INC.

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

Pre-market Notification Details

Device IDK992158
510k NumberK992158
Device Name:LACTOSORB SHEETS
ClassificationPlate, Bone
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactMichelle L Mckinley
CorrespondentMichelle L Mckinley
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-25
Decision Date1999-08-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036055868 K992158 000
00841036055851 K992158 000
00841036055844 K992158 000

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