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Pullup Clip

by S.B.M

Ref PULL0CT201Model Fixation System for ACL Reconstruction (Soft Tissue Transplant)

Pullup Clip (PULL0CT201) is a device classified as Class IIb in the EU and Class II in the US made by S.B.M, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-03760154008952), cleared under FDA 510(k) K250844 on 2 Jun 2025 (1 earlier submission) and listed in FDA GUDID since 20 Dec 2023 (UDI-DI 03760154008952), 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) K250844

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760154008952 Basic UDI-DI 03760154008952UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250844 Date2 Jun 2025DecidedStatusActive
United StatesGUDID listing GUDID Number03760154008952 UDI-DI Date20 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760154008952 registered 4 Nov 2026 Active
  • FDA 510(k) K250844 decided 2 Jun 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03760154008952 listed 20 Dec 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K202193
  2. Listed FDA GUDID 03760154008952
  3. Cleared FDA 510(k) K250844
  4. Registered EUDAMED B-03760154008952

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  • Withdrawn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
Pullup EUDAMED
Pullup Clip GUDID
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Device name
Adjustable Fixation System for Ligament Reconstruction
Model / Ref / Catalog
Fixation System for ACL Reconstruction (Soft Tissue Transplant), PULL0CT201, Cortical Tunnel, Ø 4.5 mm, Connectable plate
Primary DI / UDI-DI
03760154008952
Basic UDI-DI
B-03760154008952
510(k) Number
FDA product code
MBI
EMDN code
P091299 Osteosynthesis devices, devices for tendon and ligament synthesis - other
GMDN term
Tendon/ligament bone anchor, 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
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Fixation System for ACL Reconstruction (Soft Tissue Transplant)
PULL0CT201
GUDID
Cortical Tunnel, Ø 4.5 mm, Connectable plate
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: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K202193)

and 7 more cleared under K202193

Cleared under the same submission (K250844)

and 2 more cleared under K250844

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER.

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)