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Sterile Trac System Sp-3096

by Biomet Microfixation, Inc

Ref SP-3096

Sterile Trac System Sp-3096 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 24 Oct 2026 (Basic UDI-DI B-00888233021999), cleared under FDA 510(k) K972322 on 18 Aug 1997 and listed in FDA GUDID since 17 Jun 2020 (UDI-DI 00888233021999), active as of 7 Nov 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K972322

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-00888233021999 Basic UDI-DI 00888233021999UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888233021999 UDI-DI Date17 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972322 Date18 Aug 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00888233021999 registered 24 Oct 2026 Active
  • FDA 510(k) K972322 decided 18 Aug 1997 Active
  • FDA GUDID UDI-DI 00888233021999 listed 17 Jun 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0629-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Timeline

4 dated events

  1. Cleared FDA 510(k) K972322
  2. Listed FDA GUDID 00888233021999
  3. Recall initiated FDA recalls Z-0629-2021
  4. Registered EUDAMED B-00888233021999

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  • Withdrawn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
Sterile Trac System
Generic name
Craniofacial bone screw, non-bioabsorbable
Model / Ref / Catalog
SP-3096
Primary DI / UDI-DI
00888233021999
Basic UDI-DI
B-00888233021999
510(k) Number
FDA product code
JEY, HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Craniofacial bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4760, 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: Craniofacial fixation plate, non-bioabsorbable, non-customizedCraniofacial bone screw, non-bioabsorbable

Cleared under the same submission (K972322)

and 8 more cleared under K972322

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

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