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ToggleLoc™ with Ziploop™ 110010384

by Biomet Orthopedics, Inc.

Ref 110010384

ToggleLoc™ with Ziploop™ 110010384 is a device classified as Class IIb in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-00880304812864) and listed in FDA GUDID since 21 Jul 2017 (UDI-DI 00880304812864), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00880304812864 Basic UDI-DI 00880304812864UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304812864 UDI-DI Date21 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00880304812864 registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 00880304812864 listed 21 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00880304812864
  2. Registered EUDAMED B-00880304812864

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ToggleLoc™ with Ziploop™
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Device name
TLoc 2_9 Plunger Inserter_Implant Assembly
Model / Ref / Catalog
110010384
Primary DI / UDI-DI
00880304812864
Basic UDI-DI
B-00880304812864
FDA product code
MBI, JDR
EMDN code
P0999 Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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, non-bioabsorbable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)