Home / 510(k) Clearances / K093078

510(k) K093078

UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS by Bonutti Research, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2010
Date Received
September 30, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Bonutti Research, Inc.

  • K161628 — JAS Pulse(TM) Ultrasonic Therapy (November 10, 2016)
  • K090175 — UNITY BETA PLLA SYSTEM (September 10, 2009)
  • K082906 — UNITY BETA ANCHOR SYSTEM (October 30, 2008)
  • K062820 — UNITY ALPHA SYSTEM (March 15, 2007)
  • K060283 — TRANSET SYSTEM (February 22, 2006)
  • K052799 — MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM (December 16, 2005)
  • K033717 — TRANSET FRACTURE FIXATION SYSTEM (February 25, 2004)
  • K013177 — MULTITAK SUTURE SNAP SYSTEM (December 19, 2001)
  • K012465 — MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR (October 29, 2001)
  • K010479 — MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR (May 8, 2001)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)