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Instrumentation

by Tyber Medical 50 variants

Ref 60.530.002, 60.527.000, 60.333.009, T001000083, 770107060, 770107020, 770101020, 770107050, T001000095, 770106010, T001000098, 770105040, 770103090, T001000093, T001000052, 770104010, 770101010, 770107090, 770103050, 770103020, 770101030, T009000070, 770105050, 770103010, 770101000, T001000084

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081001136002WB Basic UDI-DI Date27 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00196449023868 UDI-DI Date15 Dec 2023ListedStatusListed 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 23 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  • Withdrawn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
A.L.P.S. mvX™
Headless Screw System Instruments
Cannulated Compression Headless Screw
Headed Screw System Instruments
VOLT™ Wrist Treatment System
Generic Name
Instrument tray, reusable
Surgical instrument/implant rack
Orthopaedic bone pin container
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Instrumentation
Model / Ref / Catalog
60.530.002, 60.527.000, 60.333.009, 770107050, T001000095, 770107020, 770101030, T001000052, T001000093, T001000084, 770101010, T001000083, 770104010, 770103050, T009000070, 770107060, 770103020, T001000098, 770103010, 770106010, 770105040, 770101020, 770105050, 770103090, 770107090, 770101000
Primary DI / UDI-DI
00196449023868, 00196449023837, 00810011360877, 00196449016716, 00810030825005, 00196449016679, 00196449016730, 00810030824909, 00810030824992, 00810030824961, 00196449016587, 00810030824947, 00196449016594, 00196449016709, 00810030825029, 00196449033386, 00196449016662, 00810030824978, 00196449016600, 00196449016624, 00196449016747, 00196449016631, 00196449016754, 00196449033393, 00196449033409, 00196449017638
Basic UDI-DI
081001136002WB
510(k) Number
FDA Product Code
FSM, PXV, HWC, LXH, HTN, HRS
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN Term
Instrument tray, reusable
Surgical instrument/implant rack
Orthopaedic bone pin container
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class I EUDAMEDGUDID
Class II GUDID
Regulation Number
878.4800, 888.3040, 888.4540, 888.3030
EU market of registration
Belgium
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 I
GUDID
Class I
Class II

Manufacturer details

EUDAMED SRN
US-MF-000011350
Authorised representative
MDSS GmbH DE-AR-000005430

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See all devices from Tyber Medical →

Properties

  • Prescription Use
  • Premarket Exempt YesGUDIDNoGUDID
  • Lot / Batch Number YesGUDIDNoGUDID
  • Manufacturing Date YesGUDIDNoGUDID

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No