Skip to content

XO Button

by Conmed Corporation

Ref PS8834, T5050, T5045, T5020, T5035, T5025, C8590, C8676

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10845854036341 Basic UDI-DI Date29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854036341 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Surgical drill guide, reusable
Tendon/ligament bone anchor, non-bioabsorbable
Tendon/ligament graft preparation station
Cannulated surgical drill bit, reusable
Device Name
Orthopedic, Non-active, Reusable Surgical Instrument, Graft Preparation
Orthopedic, Implant, Non-absorbable, Suture Anchor, Titanium, Knee, XO Button
Orthopedic, Non-active, Drill Bit, Sterile, Reusable, Badger/XO
Orthopedic, Non-active, Instrument, High Strength Guide Pin, Reusable
Model / Ref / Catalog
PS8834, T5050, T5045, T5020, T5035, T5025, C8590, C8676
Primary DI / UDI-DI
10845854036341, 20845854015619, 20845854016135, 20845854012663, 20845854015626, 20845854015947, 10845854020173, 10845854034316
Basic UDI-DI
B-10845854036341, B-20845854015619, B-20845854016135, B-20845854012663, B-20845854015626, B-20845854015947, B-10845854020173, B-10845854034316
510(k) Number
FDA Product Code
FZX, MBI, GAT, FSM, GFG
EMDN Code
L091106, P09120102, L0916, L0922
GMDN Term
Surgical drill guide, reusable
Tendon/ligament bone anchor, non-bioabsorbable
Tendon/ligament graft preparation station
Cannulated surgical drill bit, reusable
Device Class
Class I EUDAMEDGUDID
Class IIb EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4800, 888.3040, 878.5000, 878.4820
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 2.4 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
Class IIb
Class IIa
GUDID
Class I
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Sterile NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Single Use NoGUDIDYesGUDID
  • Implantable NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Reusable YesEUDAMEDNoEUDAMED
  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number
  • Expiration Date NoGUDIDYesGUDID
  • Manufacturing Date NoGUDIDYesGUDID

Other properties (15)

  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No