Home / 510(k) Clearances / K093719

510(k) K093719

PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# by Osteogenics Biomedical, Inc. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2010
Date Received
December 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
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)
  • K072076 — CYTOPLAST PTFE SUTURE (October 31, 2007)
  • 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 DZL

  • K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (September 29, 2025)
  • K251569 — Bone Screw (August 13, 2025)
  • K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN (June 27, 2025)
  • K233419 — GBR System (January 3, 2025)
  • K240321 — MP Pin flat without thread (36BMP000020/MP20) (October 17, 2024)
  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws (August 24, 2023)
  • K222367 — SAVE GBR (March 23, 2023)
  • K201210 — The Micro Screw System, Micro Screw System Basic (October 8, 2021)
  • K201561 — Membrane Screws and Membrane Tacks (October 5, 2020)