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27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights XM-127-2345

by Xenco Medical LLC

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 NumberB064XM12723451 UDI-DI Date28 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  • Withdrawn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
27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
XM-127-2345
Primary DI / UDI-DI
B064XM12723451
FDA Product Code
MAX
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Xenco Medical LLC

See all devices from Xenco Medical LLC →

Properties

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

Other properties (7)

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