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Imola Titanium Interbody Fusion System F02245-16T

by Altus Spine

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberB417F0224516T1 UDI-DI Date22 Aug 2017ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Imola Titanium Interbody Fusion System
Generic Name
Metallic spinal fusion cage, non-sterile
Model / Reference
F02245-16T
Primary DI / UDI-DI
B417F0224516T1
510(k) Number
FDA Product Code
MAX
GMDN Term
Metallic spinal fusion cage, non-sterile
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 45 Millimeter
Width — 22 Millimeter
Height — 16 Millimeter

Related devices

Category: Metallic spinal fusion cage, non-sterile

Cleared under the same submission (K170512)

Show all (12)

Other devices from Altus Spine

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • 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