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Neofit

by In2Bones SAS 5 variants

Ref P10 ST245

Neofit (P10 ST245) is a device classified as Class IIb in the EU and Class II in the US made by In2Bones SAS, registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI B-03760225714515), cleared under FDA 510(k) K160995 on 10 Jun 2016 and listed in FDA GUDID since 13 Dec 2024 (UDI-DI 03760225714515), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 25 Oct 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160995

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760225714515 Basic UDI-DI 03760225714515UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225714515 UDI-DI Date13 Dec 2024ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160995 Date10 Jun 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760225714515 registered 20 Apr 2026 Active
  • FDA 510(k) K160995 decided 10 Jun 2016 Active
  • FDA GUDID UDI-DI 03760225714515 listed 13 Dec 2024 Listed

Recalls

4 recalls · FDA

    • Terminated Z-2869-2017 FDA Class II initiated 13 Jul 2017

    The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis

  • 3 recalls, same reason

    • Terminated Z-0953-2017 FDA Class II initiated 19 Dec 2016
    • Terminated Z-0954-2017 FDA Class II initiated 19 Dec 2016
    • Terminated Z-0952-2017 FDA Class II initiated 19 Dec 2016

    Dimensional non-conformity of the thread on the screw head.

Timeline

7 dated events

  1. Cleared FDA 510(k) K160995
  2. Recall initiated FDA recalls Z-0953-2017
  3. Recall initiated FDA recalls Z-0954-2017
  4. Recall initiated FDA recalls Z-0952-2017
  5. Recall initiated FDA recalls Z-2869-2017
  6. Listed FDA GUDID 03760225714515
  7. Registered EUDAMED B-03760225714515

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

Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
P10 ST245 EUDAMED
P10 ST235 GUDID
Primary DI / UDI-DI
03760225714515
Basic UDI-DI
B-03760225714515
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
P10 ST245
GUDID
P10 ST235
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.

Manufacturer details

EUDAMED SRN
FR-MF-000005246

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from In2Bones SAS

See all devices from In2Bones SAS →

Properties

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