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CranioFit KT-T8L8H2

by Bioplate, Inc.

CranioFit KT-T8L8H2 (CF26080009) is a Class II device made by Bioplate, Inc., listed in FDA GUDID since 10 Oct 2024 (UDI-DI M384CF260800090), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM384CF260800090 UDI-DI Date10 Oct 2024ListedStatusListed 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  • Withdrawn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
CranioFit
Generic name
Cranioplasty plate, non-alterable
Model / Ref / Catalog
KT-T8L8H2, CF26080009
Primary DI / UDI-DI
M384CF260800090
FDA product code
GXN
GMDN term
Cranioplasty plate, non-alterable
Device class
Class II
Regulation number
882.5330
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Safe

Related devices

Category: Cranioplasty plate, non-alterable

Other devices from Bioplate, Inc.

See all devices from Bioplate, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)