B-ONE® Total Hip System

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

B-One Ortho Corp.

The following data is part of a premarket notification filed by B-one Ortho Corp. with the FDA for B-one® Total Hip System.

Pre-market Notification Details

• Device ID: K173380
• 510k Number: K173380
• Device Name: B-ONE® Total Hip System
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: b-One Ortho Corp. 3 Wing Drive Suite #259 Cedar Knolls, NJ 07927
• Contact: Clark Hutton
• Correspondent: Allison Geick; Lakeshore Medical Device Consulting LLC 3 Wing Drive Suite 259 Cedar Knolls, NJ 07927
• Product Code: LZO
• Subsequent Product Code: HWC
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-30
• Decision Date: 2018-08-30
• Summary: summary