413.578
by Synthes
413.578 (413578) is a Class II device made by Synthes, cleared under FDA 510(k) K093772 on 29 Mar 2010 (1 earlier submission) and listed in FDA GUDID since 14 Sep 2015 (UDI-DI 20887587048809), 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 | Number20887587048809 | Date14 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093772 | Date29 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 20887587048809
- FDA 510(k) database K093772
- FDA 510(k) database K010943
Across registries
- FDA 510(k) K093772 decided 29 Mar 2010 Active
- FDA GUDID UDI-DI 20887587048809 listed 14 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K010943
- Cleared FDA 510(k) K093772
- Listed FDA GUDID 20887587048809
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- 413.578, 413578
- Primary DI / UDI-DI
- 20887587048809
- FDA product code
- HWC, HRS, JDQ
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3040, 888.3030, 888.3010
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic bone screw (non-sliding).
- Arthrex® AR-18720VCL-08 by Arthrex, Inc.
- ACUMED 30-0444-S by ACUMED LLC
- NA SK 4514-42-2 by aap Implantate AG
- ACUMED 3050-20020 by ACUMED LLC
- 4845-140-01 00-4845-140-01 by Zimmer, Inc.
- CONNECTION SCREW FOR LOCKING ATTACHMENT PLATE STAINLESS STEEL 02.120.605 by Synthes GmbH
- DARCO DC2804004 by WRIGHT MEDICAL TECHNOLOGY, INC.
- MotionLoc® NCB® 02.03162.036 by Zimmer, Inc.
- United Hip System 5206-1055 by UNITED ORTHOPEDIC CORP.