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Gravity Compensating Accessory 903435

by Integra Neurosciences Implant (France)

Listed FDA GUDID listing, not in commercial distribution

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 Number10381780033523 UDI-DI Date1 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0458-2009 FDA Unclassified (pre-2012) initiated 3 Oct 2008

    Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Gravity Compensating Accessory
Generic Name
Ventriculo-peritoneal/atrial shunt
Model / Ref / Catalog
903435
Primary DI / UDI-DI
10381780033523
510(k) Number
FDA Product Code
JXG
GMDN Term
Ventriculo-peritoneal/atrial shunt
Device Class
Class II
Regulation Number
882.5550
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K152897)

Show all (12)

Properties

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

Other properties (7)

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