Ibs™ S65 ST190

Ibs™ S65 ST190 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 03760225715208), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number03760225715208 UDI-DI	Date1 Jun 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK170594	Date10 May 2017Decided	StatusActive

Official records

AccessGUDID record UDI-DI 03760225715208
FDA 510(k) database 510(k) number K170594

Across registries

2 registries list this device

FDA 510(k) K170594 decided 10 May 2017 Active
FDA GUDID UDI-DI 03760225715208 listed 1 Jun 2017 Listed

Timeline

2 dated events

10 May 2017 Cleared FDA 510(k) K170594
1 Jun 2017 Listed FDA GUDID 03760225715208

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Ibs™
Generic name: Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog: S65 ST190

Primary DI / UDI-DI: 03760225715208
510(k) Number: K170594
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 — 90 Millimeter
Outer Diameter — 6.5 Millimeter

Similar devices in this category

Other devices filed under Orthopaedic bone screw (non-sliding).

Other devices from IN2BONES

See all devices from IN2BONES →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9, all answered No)