NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG

Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented

NOVOSOURCE INC

The following data is part of a premarket notification filed by Novosource Inc with the FDA for Novohip Bipolar Head/novohip Vitamin E Liner/ Bone Screws/ Hole Plug.

Pre-market Notification Details

• Device ID: K140701
• 510k Number: K140701
• Device Name: NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
• Classification: Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
• Applicant: NOVOSOURCE INC 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268
• Contact: Allison Scott, Rac
• Correspondent: Allison Scott, Rac; NOVOSOURCE INC 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268
• Product Code: OQG
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-20
• Decision Date: 2014-06-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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