NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

CENTERPULSE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Natural-knee Ii Unicompartmental Knee System.

Pre-market Notification Details

• Device ID: K033810
• 510k Number: K033810
• Device Name: NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Contact: Audrey Swearingen
• Correspondent: Audrey Swearingen; CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-08
• Decision Date: 2004-03-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024249233	K033810	000
00889024249073	K033810	000
00889024249080	K033810	000
00889024249097	K033810	000
00889024249103	K033810	000
00889024249110	K033810	000
00889024249127	K033810	000
00889024249134	K033810	000
00889024249141	K033810	000
00889024249158	K033810	000
00889024249165	K033810	000
00889024249172	K033810	000
00889024249189	K033810	000
00889024249196	K033810	000
00889024249202	K033810	000
00889024249219	K033810	000
00889024249226	K033810	000
00889024249066	K033810	000