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 ID: K060121
• 510k Number: K060121
• Device Name: BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
• Classification: Neurological Stereotaxic Instrument
• Applicant: BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Lester F Padilla
• Correspondent: Lester F Padilla; BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-17
• Decision Date: 2006-03-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304716452	K060121	000
00880304643826	K060121	000
00880304461413	K060121	000