KLASSIC HD HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, 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: K100445
• 510k Number: K100445
• Device Name: KLASSIC HD HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: TOTAL JOINT ORTHOPEDICS, INC. 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089
• Contact: Kit Cariquitan
• Correspondent: Kit Cariquitan; TOTAL JOINT ORTHOPEDICS, INC. 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089
• Product Code: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: MBL
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-17
• Decision Date: 2010-12-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814703010125	K100445	000
00814703010286	K100445	000
00814703010392	K100445	000
00814703010408	K100445	000
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