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510(k) K213697

ORiGO System by Bien-Air Surgery SA — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2022
Date Received
November 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
Submission Type

Other clearances by Bien-Air Surgery SA

  • K221184 — ORiGO System (November 2, 2022)
  • K173066 — OSSEODUO Shaver and Drill System (June 22, 2018)
  • K143492 — OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (March 4, 2015)
  • K083720 — OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K (March 20, 2009)

Other clearances for product code HBC

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  • K232938 — Traus SSG30 Surgical System (September 16, 2024)
  • K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, E (May 19, 2022)
  • K193630 — hekaDrill (April 9, 2021)
  • K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools (May 12, 2019)
  • K173066 — OSSEODUO Shaver and Drill System (June 22, 2018)
  • K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h (May 15, 2017)
  • K163565 — MR8 Drill System (March 28, 2017)
  • K152960 — ELAN 4 Motor System (July 22, 2016)
  • K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (January 10, 2014)