LORENZ PECTUS SUPPORT BAR

Plate, Fixation, Bone

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Pectus Support Bar.

Pre-market Notification Details

• Device ID: K972420
• 510k Number: K972420
• Device Name: LORENZ PECTUS SUPPORT BAR
• Classification: Plate, Fixation, Bone
• Applicant: WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 -2480
• Contact: Diana Preston
• Correspondent: Diana Preston; WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 -2480
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-27
• Decision Date: 1997-08-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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