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Zero-P

by Synthes GmbH 49 variants

Ref 03.617.768Model Spine Trial Implants for Zero-P

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093762↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7611819a00528JX Basic UDI-DI 07611819389823UDI-DIDate11 Jul 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK093762 Date20 Dec 2010IssuedStatusActive

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-0104-2012 FDA Unclassified (pre-2012) initiated 23 Sep 2011 on shared 510(k) K093762

    LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Zero-P Trial Spacer Parallel Lordotic Convex Large
Model / Reference
Spine Trial Implants for Zero-P, 03.617.768
Primary DI / UDI-DI
07611819389823
Basic UDI-DI
7611819a00528JX
Direct Marketing DI
07611819389823
EMDN Code
Z12139099 Various orthopaedic and traumatology instruments - other
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Orthopaedic guidewire, reusable

Other devices from Synthes GmbH

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Properties

  • CMR Substance

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No