Surfix 185600SND
by Newdeal Sas
Surfix 185600SND is a Class II device made by Newdeal Sas, cleared under FDA 510(k) K070160 on 8 Feb 2007 (1 earlier submission) and listed in FDA GUDID since 9 Oct 2017 (UDI-DI 10381780048510), 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 | Number10381780048510 | Date9 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070160 | Date8 Feb 2007 | StatusActive |
Official records
- AccessGUDID record 10381780048510
- FDA 510(k) database K070160
- FDA 510(k) database K060473
Across registries
- FDA 510(k) K070160 decided 8 Feb 2007 Active
- FDA GUDID UDI-DI 10381780048510 listed 9 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K060473
- Cleared FDA 510(k) K070160
- Listed FDA GUDID 10381780048510
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Surfix
- Generic name
- Orthopaedic bone washer, sterile
- Model / Ref / Catalog
- 185600SND
- Primary DI / UDI-DI
- 10381780048510
- FDA product code
- HRS
- GMDN term
- Orthopaedic bone washer, sterile
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthopaedic bone washer, sterile.
- RONDO' Washer ø12mm VP-15000 by Citieffe
- Flat Washer 110008363 by Biomet Orthopedics, Inc.
- DARCO DCS07012 by WRIGHT MEDICAL TECHNOLOGY, INC.
- OsteoMed 337-3599-SP-05 by Osteomed Corp.
- A.L.P.S.® 8512-18-000 851218000 by Biomet Orthopedics, Inc.
- RONDO' Washer ø10mm VP-13000 by Citieffe
- DARCO DCS07011 by WRIGHT MEDICAL TECHNOLOGY, INC.
- Natural Nail® 47-2488-000-02 by Zimmer, Inc.