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Hex Button 400-778

by Pioneer Surgical Technology Inc.

Ref 00-2232-001-50Model 00-2232-001-25

Hex Button 400-778 (2232-01-50) is a device classified as Class IIb in the EU and Class II in the US made by Pioneer Surgical Technology Inc., registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 019108302021AC001W5), cleared under FDA 510(k) K992617 on 27 Oct 1999 and listed in FDA GUDID since 8 Jun 2016 (UDI-DI 00846468063993), active as of 8 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K992617

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number019108302021AC001W5 Basic UDI-DI 00846468063993UDI-DIDate4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846468063993 UDI-DI Date8 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK992617 Date27 Oct 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 019108302021AC001W5 registered 4 Jun 2026 Active
  • FDA 510(k) K992617 decided 27 Oct 1999 Active
  • FDA GUDID UDI-DI 00846468063993 listed 8 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K992617
  2. Listed FDA GUDID 00846468063993
  3. Registered EUDAMED 019108302021AC001W5

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Cable Ready Cable Grip System EUDAMED
Hex Button GUDID
Generic name
Implantable orthopaedic/craniofacial device connection screw
Model / Ref / Catalog
00-2232-001-25 EUDAMED
00-2232-001-50 EUDAMED
400-778 GUDID
2232-01-50 GUDID
Primary DI / UDI-DI
00846468063993
Basic UDI-DI
019108302021AC001W5
510(k) Number
FDA product code
HTN
EMDN code
P09120302 Cerclage devices, wires and binders
GMDN term
Implantable orthopaedic/craniofacial device connection screw
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-2232-001-25
00-2232-001-50
GUDID
400-778
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00846468063993: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 00846468063993: EUDAMED states Yes, FDA GUDID states No.

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: Implantable orthopaedic/craniofacial device connection screw

Cleared under the same submission (K992617)

and 8 more cleared under K992617

Similar devices in this category

Other devices filed under CERCLAGE DEVICES, WIRES AND BINDERS.

Other devices from Pioneer Surgical Technology Inc.

See all devices from Pioneer Surgical Technology Inc. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)