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MUTARS® trial extension piece for mod. prox. tibia 77500125

by implantcast GmbH

Ref 77500125Model MUT12TEPPTINST

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

CE MDR

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/MDR EUDAMED Number4048844MUT12TEPPTINSTV6 Basic UDI-DI 04048844099800UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844099800 UDI-DI Date1 Apr 2019ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mutars® EUDAMED
MUTARS® trial extension piece for mod. prox. tibia GUDID
Generic Name
General internal orthopaedic fixation system implantation kit
Model / Reference
77500125, MUT12TEPPTINST
Primary DI / UDI-DI
04048844099800
Basic UDI-DI
4048844MUT12TEPPTINSTV6
Direct Marketing DI
04048844099800
510(k) Number
FDA Product Code
LZO
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3353
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: General internal orthopaedic fixation system implantation kit

Cleared under the same submission (K181778)

Show all (12)

Other devices from implantcast GmbH

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Properties

  • Lot / Batch Number

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No