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510(k) K934861

HARD TISSUE REPLACEMENT (HTR) GRANULAR by Poly-Medics,Inc. — Product Code KKY

K934861 is an FDA 510(k) premarket notification submitted by Poly-Medics,Inc. for the device "HARD TISSUE REPLACEMENT (HTR) GRANULAR". The FDA issued a decision of Substantially Equivalent on November 4, 1994. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Poly-Medics,Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1994
Date Received
October 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class
Class II
Regulation Number
878.3500
Review Panel
SU
Submission Type

Other clearances by Poly-Medics,Inc.

  • K960988 — LACTOSORB TRAUMA PLATING SYSTEM (April 10, 1996)
  • K955729 — LACTOSORB TRAUMA PLATING SYSTEM (February 14, 1996)
  • K954443 — LACTOSORB SUTURE ANCHOR (January 31, 1996)
  • K951658 — LACTOSORB POP RIVET (July 25, 1995)

Other clearances for product code KKY

  • K211514 — Longeviti PorousFit implant (July 15, 2021)
  • K161052 — OsteoFab Patient Specific Facial Device (July 20, 2016)
  • K160988 — Biopor, AOC Porous Polyethylene, Cerepor (July 14, 2016)
  • K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (April 16, 2015)
  • K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (July 28, 2014)
  • K140437 — SU-POR SURGICAL IMPLANT (June 13, 2014)
  • K133046 — OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (May 14, 2014)
  • K123908 — OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES (July 31, 2013)
  • K111323 — SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS (November 16, 2011)
  • K103010 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (October 26, 2010)

FDA data resources