Ponto M52169
Ponto M52169 is a craniofacial bone screw (FDA Class II; FDA product code MAH, Hearing Aid, Bone Conduction, Implanted) made by Oticon Medical AB, listed in FDA GUDID since 26 Nov 2015 (UDI-DI 05712149009619), registry data as of 12 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05712149009619 | Date26 Nov 2015 | StatusListed |
Official records
- AccessGUDID record 05712149009619
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Ponto
- Generic name
- Craniofacial bone screw, non-bioabsorbable
- Model / Ref / Catalog
- M52169
- Primary DI / UDI-DI
- 05712149009619
- FDA product code
- MAH
- GMDN term
- Craniofacial bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 874.3302
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 4 MillimeterOuter Diameter — 4.5 MillimeterLength — 9 Millimeter
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