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My Spine Low Profile Placement Guides 7.0507

by Medacta International EUDAMEDGUDID

Active European Union

Ref 7.0507Model Spine Drill guide - not sterile

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274VSP0142N00KS Basic UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030877889 UDI-DIDate31 Aug 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
MySpine LP guide T07 EUDAMED
My Spine Low Profile Placement Guides GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use
Model / Reference
7.0507, Spine Drill guide - not sterile
Primary DI / UDI-DI
07630030877889
Basic UDI-DI
764014274VSP0142N00KS
510(k) Number
FDA Product Code
PQC
EMDN Code
K01020114 Minimally invasive surgery guides, single-use
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3070
Market of Registration
Italy
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

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: 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
  • Manufacturing Date: No