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510(k) K171037

PoreStar Patient Specific Implant by Anatomics Pty, Ltd. — Product Code JOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2017
Date Received
April 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic, Porous Polyethylene
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Other clearances by Anatomics Pty, Ltd.

  • K200532 — StarPore (June 2, 2020)

Other clearances for product code JOF

  • K200532 — StarPore (June 2, 2020)
  • K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT (February 3, 2009)
  • K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT (November 20, 2000)
  • K771726 — BIOSPONGE STAPES PISTON (September 26, 1977)
  • K771727 — BIOSPONGE RECONSTRUCTION DISCS (September 26, 1977)