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510(k) K191916

Stryker CMF MEDPOR Priority Customized Implant Kit by Stryker Leibinger GmbH & Co KG — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2019
Date Received
July 17, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

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  • K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (January 20, 2016)
  • K143173 — Stryker CMF MEDPOR Customized Implant (March 23, 2015)
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  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
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