STRYKER PLATING SYSTEM BASIC FRAGMENT SET

Plate, Fixation, Bone

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Plating System Basic Fragment Set.

Pre-market Notification Details

• Device ID: K012162
• 510k Number: K012162
• Device Name: STRYKER PLATING SYSTEM BASIC FRAGMENT SET
• Classification: Plate, Fixation, Bone
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Karen Ariemma
• Correspondent: Karen Ariemma; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-11
• Decision Date: 2001-08-31
• Summary: summary

NIH GUDID Devices

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