NATURAL-KNEE II CONSTRAINED KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

SULZER ORTHOPEDICS, INC.

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

Pre-market Notification Details

• Device ID: K973412
• 510k Number: K973412
• Device Name: NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Contact: Lori Kleinschrodt Holder
• Correspondent: Lori Kleinschrodt Holder; SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-09-09
• Decision Date: 1997-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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