PARAGON HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

GLOBAL MANUFACTURING TECHNOLOGY

The following data is part of a premarket notification filed by Global Manufacturing Technology with the FDA for Paragon Hip System.

Pre-market Notification Details

• Device ID: K123782
• 510k Number: K123782
• Device Name: PARAGON HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: GLOBAL MANUFACTURING TECHNOLOGY 1331 H STREET NW Washington, DC 20005
• Contact: Hollace S Rhodes
• Correspondent: Hollace S Rhodes; GLOBAL MANUFACTURING TECHNOLOGY 1331 H STREET NW Washington, DC 20005
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-10
• Decision Date: 2013-03-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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