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510(k) K072076

CYTOPLAST PTFE SUTURE by Osteogenics Biomedical, Inc. — Product Code NBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2007
Date Received
July 30, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class
Class II
Regulation Number
878.5035
Review Panel
SU
Submission Type

Other clearances by Osteogenics Biomedical, Inc.

  • K201187 — Cytoplast Titanium-Reinforced PTFE Membranes (January 23, 2021)
  • K171774 — RPM Reinforced PTFE Mesh (October 19, 2017)
  • K093719 — PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# (March 1, 2010)
  • K013764 — IMMIX BONE GRAFT EXTENDER (May 16, 2002)
  • K003028 — CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC (November 24, 2000)
  • K993610 — CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 (March 2, 2000)
  • K984230 — OSTEO-MESH TM-300 (February 4, 1999)

Other clearances for product code NBY

  • K231277 — TissueStat (November 9, 2023)
  • K192088 — GOLNIT Non-aborbable PTFE Surgical Suture (September 4, 2019)
  • K180992 — Biotex (July 16, 2019)
  • K191317 — StitchKit (July 12, 2019)
  • K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture (October 11, 2018)
  • K180630 — PTFE SURGICAL SUTURE (April 6, 2018)
  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K173335 — Gazelle PTFE and Suture Delivery Device (February 8, 2018)
  • K170842 — WEGO-PTFE (July 31, 2017)
  • K163049 — GOLNIT Non-Absorbable PTFE Surgical Suture (June 21, 2017)