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510(k) K002629

SILMAX CONTOUR CARVING BLOCK IMPLANT by Pillar Surgical, Inc. — Product Code JOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2000
Date Received
August 23, 2000
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 Pillar Surgical, Inc.

  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K992239 — PILLAR CHIN IMPLANT (November 22, 1999)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K991970 — SCAREASE SHEETS & SCAREASE GEL (October 25, 1999)
  • K954382 — PROLASTIC SHEETING (November 29, 1995)

Other clearances for product code JOF

  • K200532 — StarPore (June 2, 2020)
  • K171037 — PoreStar Patient Specific Implant (December 27, 2017)
  • K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT (February 3, 2009)
  • K771726 — BIOSPONGE STAPES PISTON (September 26, 1977)
  • K771727 — BIOSPONGE RECONSTRUCTION DISCS (September 26, 1977)