ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Orthopedic Salvage System (oss) 9cm Cobalt - Chrome Tibial Bodies.

Pre-market Notification Details

Device IDK083827
510k NumberK083827
Device Name:ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactGary Baker
CorrespondentGary Baker
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-23
Decision Date2009-02-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304840416 K083827 000
00880304652217 K083827 000
00880304652200 K083827 000
00880304652194 K083827 000
00880304510081 K083827 000

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