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Axle Interspinous Fusion System X060-0259

by Xtant Medical Holdings, 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 NumberM697X06002591 UDI-DI Date17 Aug 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  • Withdrawn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
Axle Interspinous Fusion System
Generic Name
Polymeric spinal interbody fusion cage
Model / Reference
X060-0259
Primary DI / UDI-DI
M697X06002591
FDA Product Code
PEK
GMDN Term
Polymeric spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 37 Millimeter
Width — 8 Millimeter

Related devices

Category: Polymeric spinal interbody fusion cage

Other devices from Xtant Medical Holdings, Inc.

See all devices from Xtant Medical Holdings, Inc. →

Properties

  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

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