510(k) K080363
- Device
- BAHA CORDELLE II
- Applicant
- COCHLEAR BONE ANCHORED SYSTEMS AB
- 510(k) number
- K080363
- Product code
- MAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-10
- Date received
- 2008-02-11
- Regulation
- 874.3300
- Classification name
- Hearing Aid, Bone Conduction, Implanted
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SEAN BUNDY
- Address
- 400 Inverness Pkwy. Suite 400 Englewood CO US 80112 80112
FDA Registration Numbers#
- 3014579188
- 3007051929
- 3006405073
- 3013177549
- 3007367732
- 3009307953
- 9612468
- 3005900820
- 3009632672
- 3003847101
- 3005216725
- 9616024
Source Documents#
Other 510(k) Records For Product Code MAH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | 2021-03-03 |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | 2018-12-19 |
| K152820 | Ponto Bone Anchored Hearing System | Oticon Medical AB | 2016-01-22 |
| K152067 | Ponto bone anchored hearing system | Oticon Medical AB | 2015-11-23 |
| K150555 | BA400 14mm Abutment | Cochlear Americas | 2015-07-15 |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | Oticon Medical AB | 2015-01-21 |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | Cochlear Americas | 2012-10-12 |
| K121228 | PONTO BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2012-09-07 |
| K112053 | OBC BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2011-11-18 |
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Nobelpharma USA, Inc. | 1999-06-28 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases