STRYKER TRAUMA PELVIC SET

Appliance, Fixation, Nail/blade/plate Combination, Single Component

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Trauma Pelvic Set.

Pre-market Notification Details

• Device ID: K001614
• 510k Number: K001614
• Device Name: STRYKER TRAUMA PELVIC SET
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Single Component
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Mary-catherine Dillon
• Correspondent: Mary-catherine Dillon; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: KTW
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-05-25
• Decision Date: 2000-08-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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