Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
FDA 510(k) K142678 · Oticon Medical AB
510(k) numberK142678
Submission
- Device name
- Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
- Applicant
- Oticon Medical AB
Askim, SE - Received
- September 19, 2014
- Decision date
- January 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAH – Hearing Aid, Bone Conduction, Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3302
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code MAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261142 | Ponto 5 Mini; Ponto 5 SuperpowerMAH · Special | Oticon Medical AB | 08/26/2026SE |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery KitMAH · Special | Oticon Medical AB | 03/03/2021SE |
| K182116 | BA310 Abutment, BIA310 Implant/AbutmentMAH · Traditional | Cochlear Americas | 12/19/2018SE |
| K152820 | Ponto Bone Anchored Hearing SystemMAH · Traditional | Oticon Medical AB | 01/22/2016SE |
| K152067 | Ponto bone anchored hearing systemMAH · Traditional | Oticon Medical AB | 11/23/2015SE |
| K150555 | BA400 14mm AbutmentMAH · Traditional | Cochlear Americas | 07/15/2015SE |
| K121317 | Cochlear Baha Implant SystemMAH · Traditional | Cochlear Americas | 10/12/2012SE |
| K121228 | Ponto Bone Anchored Hearing SystemMAH · Traditional | Oticon Medical AB | 09/07/2012SE |
| K112053 | Obc Bone Anchored Hearing SystemMAH · Traditional | Oticon Medical AB | 11/18/2011SE |
| K080363 | Baha Cordelle IIMAH · Traditional | Cochlear Bone Anchored Systems AB | 04/10/2008SE |
More from Cochlear Bone Anchored Systems AB
| 510(k) | Device | Decision |
|---|---|---|
| K261142 | Ponto 5 Mini; Ponto 5 SuperpowerMAH · Special | 08/26/2026SE |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSPFO · Traditional | 07/10/2024SE |
| K213733 | Ponto 5 SuperPowerLXB · Special | 12/16/2021SE |
| K211640 | Ponto 5 MiniLXB · Special | 08/10/2021SE |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery KitMAH · Special | 03/03/2021SE |
| K190540 | Ponto 4LXB · Traditional | 05/02/2019SE |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerLXB · Traditional | 09/29/2016SE |
| K152820 | Ponto Bone Anchored Hearing SystemMAH · Traditional | 01/22/2016SE |
| K152067 | Ponto bone anchored hearing systemMAH · Traditional | 11/23/2015SE |
| K141616 | Sterilization CassetteKCT · Traditional | 09/23/2014SE |
Questions and answers
When was Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm cleared by the FDA?
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (K142678) received a 510(k) decision of Substantially Equivalent on January 21, 2015, 124 days after the submission was received.
What is the product code of K142678?
The FDA product code is MAH – Hearing Aid, Bone Conduction, Implanted, a Class II (moderate risk) device regulated under 21 CFR 874.3302.