Skip to content

ACIS® ProTi 360™ HL 208843333

by Tyber Medical

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 Number00819917022384 UDI-DI Date25 May 2019ListedStatusListed 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  • Withdrawn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
ACIS® ProTi 360™ HL
Generic Name
Metal-polymer composite spinal interbody fusion cage
Model / Ref / Catalog
208843333
Primary DI / UDI-DI
00819917022384
FDA Product Code
ODP
GMDN Term
Metal-polymer composite spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Metal-polymer composite spinal interbody fusion cage

Other devices from Tyber Medical

See all devices from Tyber Medical →

Properties

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

Other properties (7)

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