CORAIL

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

LANDOS, INC.

The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Corail.

Pre-market Notification Details

• Device ID: K953111
• 510k Number: K953111
• Device Name: CORAIL
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854
• Contact: Norman F Estrin
• Correspondent: Norman F Estrin; LANDOS, INC. 9109 COPENHAVER DR. Potomac, MD 20854
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-03
• Decision Date: 1996-12-27
• Summary: summary