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Facet Sterile Instrument Kit - Cervical FIC-1000

by Surgentec LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810131882808 UDI-DIDate6 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Facet Sterile Instrument Kit - Cervical
Generic Name
Implantable cervical facet joint distractor
Model / Reference
FIC-1000
Primary DI / UDI-DI
00810131882808
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 (K251714)

Other devices from Surgentec LLC

See all devices from Surgentec LLC →

Properties

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

Other properties (6)

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