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510(k) K152463

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant by Poriferous, LLC — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2016
Date Received
August 28, 2015
Clearance Type
Traditional
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

Other clearances by Poriferous, LLC

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  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)
  • K091011 — PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (April 22, 2009)