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510(k) K021889

SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) by Surgical Technology Laboratories, Inc. — Product Code KKY

K021889 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc. for the device "SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)". The FDA issued a decision of Substantially Equivalent on October 16, 2002. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Surgical Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2002
Date Received
June 7, 2002
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 Surgical Technology Laboratories, Inc.

  • K170582 — Saf-T-Vac Smoke and Fluid Evacuator (April 14, 2017)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K983754 — STANDARD CHIN (November 20, 1998)
  • K964443 — SURGIFORM ANATOMICAL MALAR (December 20, 1996)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)
  • K831078 — STRAITH ORAL AIRWAY (June 24, 1983)
  • K801074 — STRAITH NASAL IMPLANT (June 17, 1980)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)
  • K801075 — STRAITH CHISEL FORCEPS (May 20, 1980)

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