Biolox® Delta Ceramic Heads, Biolox® Delta Option Ceramic Heads MR Labeling

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

Biomet UK Ltd.

The following data is part of a premarket notification filed by Biomet Uk Ltd. with the FDA for Biolox® Delta Ceramic Heads, Biolox® Delta Option Ceramic Heads Mr Labeling.

Pre-market Notification Details

• Device ID: K200959
• 510k Number: K200959
• Device Name: Biolox® Delta Ceramic Heads, Biolox® Delta Option Ceramic Heads MR Labeling
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: Biomet UK Ltd. Waterton Industrial Estate Brigend, GB Cf31 3xa
• Contact: Caleb Barylski
• Correspondent: Caleb Barylski; Biomet UK Ltd. Waterton Industrial Estate Brigend, GB Cf31 3xa
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: MAY
• Subsequent Product Code: OQG
• Subsequent Product Code: OQH
• Subsequent Product Code: OQI
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-10
• Decision Date: 2020-07-29