BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS

Neurological Stereotaxic Instrument

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Biomet Pre-calibrated Computer Aided Surgery Navigation Instruments For Hip Applications.

Pre-market Notification Details

Device IDK060121
510k NumberK060121
Device Name:BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
ClassificationNeurological Stereotaxic Instrument
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581 -0587
ContactLester F Padilla
CorrespondentLester F Padilla
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-17
Decision Date2006-03-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304716452 K060121 000
00880304643826 K060121 000
00880304461413 K060121 000

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