Ibs™ S35 ST130
by IN2BONES
Ibs™ S35 ST130 is a Class II device made by IN2BONES, cleared under FDA 510(k) K131920 on 1 May 2014 and listed in FDA GUDID since 28 Aug 2015 (UDI-DI 03760225711804), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03760225711804 | Date28 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131920 | Date1 May 2014 | StatusActive |
Official records
- AccessGUDID record 03760225711804
- FDA 510(k) database K131920
Across registries
- FDA 510(k) K131920 decided 1 May 2014 Active
- FDA GUDID UDI-DI 03760225711804 listed 28 Aug 2015 Listed
Recalls
-
- Ongoing Z-1319-2024
- Ongoing Z-1320-2024
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
-
- Terminated Z-0397-2016
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Timeline
- Cleared FDA 510(k) K131920
- Listed FDA GUDID 03760225711804
- Recall initiated FDA recalls Z-0397-2016
- Recall initiated FDA recalls Z-1319-2024
- Recall initiated FDA recalls Z-1320-2024
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- Withdrawn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
- S35 ST130
- Primary DI / UDI-DI
- 03760225711804
- 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 — 30 MillimeterOuter Diameter — 3.5 Millimeter
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