ATLAS III ACETABULAR CUP

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

FOURNITURES HOSPITALIERES

The following data is part of a premarket notification filed by Fournitures Hospitalieres with the FDA for Atlas Iii Acetabular Cup.

Pre-market Notification Details

• Device ID: K961388
• 510k Number: K961388
• Device Name: ATLAS III ACETABULAR CUP
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: FOURNITURES HOSPITALIERES 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852
• Contact: Ben Van Der Kooij
• Correspondent: Ben Van Der Kooij; FOURNITURES HOSPITALIERES 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-04-10
• Decision Date: 1997-04-03
• Summary: summary

NIH GUDID Devices

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