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Spinal Instrument 99781310

by Clariance, Inc.

Ref 99781310

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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 Number0370078069923MAFB Basic UDI-DI 03700780627950UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780627950 UDI-DI Date22 May 2018ListedStatusListed 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

1 recall · FDA

    • Terminated Z-1986-2019 FDA Class III initiated 1 Jul 2019

    Potential for the polyaxial screw to become disassembled during implant.

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  • Withdrawn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
Ratcheting Torque Limiter EUDAMED
Spinal Instrument GUDID
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Spinal Instrumentation
Model / Ref / Catalog
99781310
Primary DI / UDI-DI
03700780627950
Basic UDI-DI
0370078069923MAFB
510(k) Number
FDA Product Code
MNH, MNI, NKB
EMDN Code
P090799 Spinal prostheses and stabilisation systems - other
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3070
EU market of registration
France
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 II

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K153326)

Show all (12)

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No