Hintermann Series 319361
Hintermann Series 319361 is a Class I device made by Dt Medtech, LLC, cleared under FDA 510(k) K171004 on 7 Nov 2017 and listed in FDA GUDID since 5 Oct 2018 (UDI-DI B095319361), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB095319361 | Date5 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171004 | Date7 Nov 2017 | StatusActive |
Official records
- FDA 510(k) database K171004
Across registries
- FDA 510(k) K171004 decided 7 Nov 2017 Active
- FDA GUDID UDI-DI B095319361 listed 5 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K171004
- Listed FDA GUDID B095319361
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hintermann Series
- Generic name
- Osteotomy guide, reusable
- Model / Ref / Catalog
- 319361
- Primary DI / UDI-DI
- B095319361
- FDA product code
- FZX
- GMDN term
- Osteotomy guide, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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