ActivaScrew™ B-ALC-3540

ActivaScrew™ B-ALC-3540 is a Class II device made by Bioretec Oy, cleared under FDA 510(k) K081392 on 18 Jun 2008 and listed in FDA GUDID since 21 Aug 2015 (UDI-DI E302BALC35409), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberE302BALC35409 UDI-DI	Date21 Aug 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK081392	Date18 Jun 2008Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K081392

Across registries

2 registries list this device

FDA 510(k) K081392 decided 18 Jun 2008 Active
FDA GUDID UDI-DI E302BALC35409 listed 21 Aug 2015 Listed

Timeline

2 dated events

18 Jun 2008 Cleared FDA 510(k) K081392
21 Aug 2015 Listed FDA GUDID E302BALC35409

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: ActivaScrew™
Generic name: Bioabsorbable orthopaedic bone screw
Model / Ref / Catalog: B-ALC-3540

Primary DI / UDI-DI: E302BALC35409
510(k) Number: K081392
FDA product code: HWC
GMDN term: Bioabsorbable orthopaedic bone screw

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

MRI safety: MR Safe

Size: Width — 3.5 Millimeter
Length — 40 Millimeter

Similar devices in this category

Other devices filed under Bioabsorbable orthopaedic bone screw.

Other devices from Bioretec Oy

See all devices from Bioretec Oy →

Properties

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

Other properties (8, all answered No)