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510(k) K200532

StarPore by Anatomics Pty, Ltd. — Product Code JOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2020
Date Received
March 2, 2020
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.

  • K171037 — PoreStar Patient Specific Implant (December 27, 2017)

Other clearances for product code JOF

  • K171037 — PoreStar Patient Specific Implant (December 27, 2017)
  • 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)