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Zero-P VA 04.647.229S

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034751238 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0455-2014 FDA Class II initiated 30 Sep 2013

    A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Zero-P VA
Generic Name
Polymeric spinal interbody fusion cage
Model / Ref / Catalog
04.647.229S, 04647229S
Primary DI / UDI-DI
10705034751238
510(k) Number
FDA Product Code
OVE
GMDN Term
Polymeric spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K112068)

Show all (12)

Other devices from Synthes

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Properties

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

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No