GAS PLASMA STERILIZATION

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Gas Plasma Sterilization.

Pre-market Notification Details

• Device ID: K972774
• 510k Number: K972774
• Device Name: GAS PLASMA STERILIZATION
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Ralph H Larsen
• Correspondent: Ralph H Larsen; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: JWH
• Subsequent Product Code: LPH
• Subsequent Product Code: MLR
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-24
• Decision Date: 1999-05-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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