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Pcfb-612

by TDM Co., Ltd.

Ref PCFB-612

Pcfb-612 is a device classified as Class IIb in the EU and Class II in the US made by TDM Co., Ltd., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-08800043900662), cleared under FDA 510(k) K191057 on 19 Mar 2020 and listed in FDA GUDID since 15 May 2020 (UDI-DI 08800043900662), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191057

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800043900662 Basic UDI-DI 08800043900662UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800043900662 UDI-DI Date15 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191057 Date19 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800043900662 registered 5 Nov 2026 Active
  • FDA 510(k) K191057 decided 19 Mar 2020 Active
  • FDA GUDID UDI-DI 08800043900662 listed 15 May 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191057
  2. Listed FDA GUDID 08800043900662
  3. Registered EUDAMED B-08800043900662

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  • Withdrawn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
Non-Sterile Pectus Bar System
Generic name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Model / Ref / Catalog
PCFB-612
Primary DI / UDI-DI
08800043900662
Basic UDI-DI
B-08800043900662
510(k) Number
FDA product code
HRS
EMDN code
P9099 Implantable prosthetic devices - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 20 Millimeter
Width — 12 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
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: Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K191057)

and 8 more cleared under K191057

Similar devices in this category

Other devices filed under IMPLANTABLE PROSTHETIC AND OSTEOSYNTHESIS DEVICES - VARIOUS.

Other devices from TDM Co., Ltd.

See all devices from TDM Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)