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Fix2Lock BIS-2610-1720

by OSTEONIC CO., Ltd.

Ref BIS-2610-1720

Fix2Lock BIS-2610-1720 is a device classified as Class III in the EU and Class II in the US made by OSTEONIC CO., Ltd., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-08800071018766), cleared under FDA 510(k) K202806 on 17 Jun 2021 and listed in FDA GUDID since 6 Jul 2021 (UDI-DI 08800071018766), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202806

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800071018766 Basic UDI-DI 08800071018766UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800071018766 UDI-DI Date6 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202806 Date17 Jun 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800071018766 registered 3 Nov 2026 Active
  • FDA 510(k) K202806 decided 17 Jun 2021 Active
  • FDA GUDID UDI-DI 08800071018766 listed 6 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202806
  2. Listed FDA GUDID 08800071018766
  3. Registered EUDAMED B-08800071018766

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
KINEX FIX2LOCK Biocomposite EUDAMED
Fix2Lock GUDID
Generic name
Tendon/ligament bone anchor, bioabsorbable
Model / reference
BIS-2610-1720
Primary DI / UDI-DI
08800071018766
Basic UDI-DI
B-08800071018766
510(k) Number
FDA product code
MAI, MBI
EMDN code
P09120102 Anchors, tendon and ligament synthesis
GMDN term
Tendon/ligament bone anchor, bioabsorbable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3030, 888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Tendon/ligament bone anchor, bioabsorbable

Cleared under the same submission (K202806)

and 8 more cleared under K202806

Similar devices in this category

Other devices filed under ANCHORS, TENDON AND LIGAMENT SYNTHESIS.

Other devices from OSTEONIC CO., Ltd.

See all devices from OSTEONIC CO., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)