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StaXx® IBL System 11-1437

by Spine Wave, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10840642101041 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
StaXx® IBL System
Generic Name
Polymeric spinal fusion cage, sterile
Model / Ref / Catalog
11-1437
Primary DI / UDI-DI
10840642101041
FDA Product Code
MAX
GMDN Term
Polymeric spinal fusion cage, sterile
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Size
Height — 8 Millimeter
Width — 18 Millimeter
Length — 37 Millimeter

Related devices

Category: Polymeric spinal fusion cage, sterile

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →

Properties

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

Other properties (9)

  • Implantable: No
  • 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