UHR UNIVERSAL6HIP REPLACEMENT

Prosthesis, Hip, Hemi-, Femoral, Metal

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Uhr Universal6hip Replacement.

Pre-market Notification Details

• Device ID: K800207
• 510k Number: K800207
• Device Name: UHR UNIVERSAL6HIP REPLACEMENT
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal
• Applicant: OSTEONICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KWL
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-01-30
• Decision Date: 1980-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327016772	K800207	000
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