Klassic HD® Hip System

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

Total Joint Orthopedics, Inc.

The following data is part of a premarket notification filed by Total Joint Orthopedics, Inc. with the FDA for Klassic Hd® Hip System.

Pre-market Notification Details

• Device ID: K180929
• 510k Number: K180929
• Device Name: Klassic HD® Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106
• Contact: Chris Weaber
• Correspondent: Chris Weaber; Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106
• Product Code: LZO
• Subsequent Product Code: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: MBL
• Subsequent Product Code: OQG
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-09
• Decision Date: 2018-05-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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