STRYKER PATIENT SPECIFIC POLYMER IMPLANT— 510(k) K103010

Clearance details

Applicant

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Product code

Code KKY

Device class

Class 2

Regulation

21 CFR 878.3500

Advisory panel

General, Plastic Surgery

Date received

2010-10-12

Decision date

2010-10-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Mahwah, NJ, US

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• Z-0975-2014 — Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20131206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103010.