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Axle Interspinous Fusion System T080-4230

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 NumberM697T08042301 UDI-DIDate30 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  • Withdrawn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
Orthopaedic inorganic implant inserter/extractor, reusable
Model / Reference
T080-4230
Primary DI / UDI-DI
M697T08042301
FDA Product Code
HWA
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 30 Millimeter
Width — 42 Millimeter

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Other devices from Xtant Medical Holdings, Inc.

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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