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TraumaOne SYSTEM SP-2978

by Biomet Microfixation, Inc

Ref SP-2978

TraumaOne SYSTEM SP-2978 is a device classified as Class IIb in the EU and Class II in the US made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00888233021036), cleared under FDA 510(k) K081067 on 9 May 2008 and listed in FDA GUDID since 16 Jun 2020 (UDI-DI 00888233021036), 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) K081067

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-00888233021036 Basic UDI-DI 00888233021036UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888233021036 UDI-DI Date16 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK081067 Date9 May 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00888233021036 registered 23 Oct 2026 Active
  • FDA 510(k) K081067 decided 9 May 2008 Active
  • FDA GUDID UDI-DI 00888233021036 listed 16 Jun 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K081067
  2. Listed FDA GUDID 00888233021036
  3. Registered EUDAMED B-00888233021036

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  • Withdrawn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
TraumaOne SYSTEM
Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device name
Mandibular System Plates
Model / Ref / Catalog
SP-2978
Primary DI / UDI-DI
00888233021036
Basic UDI-DI
B-00888233021036
510(k) Number
FDA product code
JEY
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4760
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K081067)

and 8 more cleared under K081067

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)