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Axle Interspinous Fusion System X080-382819-12T-STR

by Xtant Medical Holdings, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM697X08038281912TSTR1 UDI-DIDate31 Oct 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Axle Interspinous Fusion System
Generic Name
Metallic spinal interbody fusion cage
Model / Reference
X080-382819-12T-STR
Primary DI / UDI-DI
M697X08038281912TSTR1
FDA Product Code
OVD
GMDN Term
Metallic spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization
Size
Height — 19 Millimeter
Angle — 12 degree
Width — 38 Millimeter
Length — 28 Millimeter

Related devices

Category: Metallic spinal interbody fusion cage

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Properties

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

Other properties (9)

  • 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