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510(k) K203807

Ponto Bone Anchored Hearing System, MONO Surgery Kit by Oticon Medical AB — Product Code MAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2021
Date Received
December 28, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction, Implanted
Device Class
Class II
Regulation Number
874.3302
Review Panel
EN
Submission Type

Other clearances by Oticon Medical AB

  • K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (July 10, 2024)
  • K213733 — Ponto 5 SuperPower (December 16, 2021)
  • K211640 — Ponto 5 Mini (August 10, 2021)
  • K190540 — Ponto 4 (May 2, 2019)
  • K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (September 29, 2016)
  • K152820 — Ponto Bone Anchored Hearing System (January 22, 2016)
  • K152067 — Ponto bone anchored hearing system (November 23, 2015)
  • K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing (January 21, 2015)
  • K141616 — STERILIZATION CASSETTE (September 23, 2014)
  • K132775 — PONTO PLUS AND PONTO PLUS POWER (December 9, 2013)

Other clearances for product code MAH

  • K182116 — BA310 Abutment, BIA310 Implant/Abutment (December 19, 2018)
  • K152820 — Ponto Bone Anchored Hearing System (January 22, 2016)
  • K152067 — Ponto bone anchored hearing system (November 23, 2015)
  • K150555 — BA400 14mm Abutment (July 15, 2015)
  • K142678 — Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing (January 21, 2015)
  • K121317 — COCHLEAR BAHA IMPLANT SYSTEM (October 12, 2012)
  • K121228 — PONTO BONE ANCHORED HEARING SYSTEM (September 7, 2012)
  • K112053 — OBC BONE ANCHORED HEARING SYSTEM (November 18, 2011)
  • K080363 — BAHA CORDELLE II (April 10, 2008)
  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)