Ibs™ S65 ST285
by IN2BONES
Ibs™ S65 ST285 is a Class II device made by IN2BONES, cleared under FDA 510(k) K170594 on 10 May 2017 and listed in FDA GUDID since 1 Jun 2017 (UDI-DI 03760225715246), 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 | Number03760225715246 | Date1 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170594 | Date10 May 2017 | StatusActive |
Official records
- AccessGUDID record 03760225715246
- FDA 510(k) database K170594
Across registries
- FDA 510(k) K170594 decided 10 May 2017 Active
- FDA GUDID UDI-DI 03760225715246 listed 1 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K170594
- Listed FDA GUDID 03760225715246
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ibs™
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- S65 ST285
- Primary DI / UDI-DI
- 03760225715246
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 85 MillimeterOuter Diameter — 6.5 Millimeter
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