Skip to content

ION 65 Facet Implant - Sterile TI-K-65

by Surgentec LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810131881825 UDI-DI Date9 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ION 65 Facet Implant - Sterile
Generic Name
Implantable cervical facet joint distractor
Model / Reference
TI-K-65
Primary DI / UDI-DI
00810131881825
510(k) Number
FDA Product Code
MRW
GMDN Term
Implantable cervical facet joint distractor
Device Class
U
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243265)

Show all (12)

Cleared under the same submission (K261209)

Other devices from Surgentec LLC

See all devices from Surgentec LLC →

Properties

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

Other properties (7)

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