Ponto Bone Anchored Hearing System
FDA 510(k) clearance K152820 · decided 2016-01-22
Clearance details
- K-number
- K152820
- Device name
- Ponto Bone Anchored Hearing System
- Applicant
- Oticon Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2015-09-28
- Decision date
- 2016-01-22
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- MAH
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Askim, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ponto Bone Anchored Hearing System, MONO Surgery Kit (K203807) | Oticon Medical AB | 2021-03-03 |
| BA310 Abutment, BIA310 Implant/Abutment (K182116) | Cochlear Americas | 2018-12-19 |
| Ponto bone anchored hearing system (K152067) | Oticon Medical AB | 2015-11-23 |
| BA400 14mm Abutment (K150555) | Cochlear Americas | 2015-07-15 |
| Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (K142678) | Oticon Medical AB | 2015-01-21 |
| COCHLEAR BAHA IMPLANT SYSTEM (K121317) | Cochlear Americas | 2012-10-12 |
| PONTO BONE ANCHORED HEARING SYSTEM (K121228) | Oticon Medical AB | 2012-09-07 |
| OBC BONE ANCHORED HEARING SYSTEM (K112053) | Oticon Medical AB | 2011-11-18 |
| BAHA CORDELLE II (K080363) | Cochlear Bone Anchored Systems AB | 2008-04-10 |
| BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (K984162) | Nobelpharma USA, Inc. | 1999-06-28 |
Recalls involving this device
No recalls on record reference this clearance.