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Pit'stop®

by In2Bones SAS 5 variants

Ref M20 SP013

Pit'stop® (M20 SP013) 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-03760225713365), cleared under FDA 510(k) K170688 on 28 Nov 2017 and listed in FDA GUDID since 20 Apr 2018 (UDI-DI 03760225713365), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170688

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760225713365 Basic UDI-DI 03760225713365UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760225713365 UDI-DI Date20 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170688 Date28 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760225713365 registered 20 Apr 2026 Active
  • FDA 510(k) K170688 decided 28 Nov 2017 Active
  • FDA GUDID UDI-DI 03760225713365 listed 20 Apr 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170688
  2. Listed FDA GUDID 03760225713365
  3. Registered EUDAMED B-03760225713365

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  • Withdrawn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
M20 SP013
Primary DI / UDI-DI
03760225713365
Basic UDI-DI
B-03760225713365
510(k) Number
FDA product code
HWC
EMDN code
P090605 Foot endorthesis
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Width — 13 Millimeter
Length — 14.9 Millimeter

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.

Manufacturer details

EUDAMED SRN
FR-MF-000005246

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Properties

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