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4CIS® Spinal System and 4CIS® Low Back System 68-11029

by Alpha Ai Co., Ltd. FDA registration: United States GUDID

Product code MNH

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800313887679 UDI-DIDate15 Apr 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

GUDID · synced 23 Oct 2026

Trade Name
4CIS® Spinal System and 4CIS® Low Back System
Generic Name
Bone-screw internal spinal fixation system connector
Model / Ref / Catalog
68-11029
Primary DI / UDI-DI
08800313887679
510(k) Number
FDA Product Code
MNH, MNI
GMDN Term
Bone-screw internal spinal fixation system connector
Device Class
Class II
Regulation Number
888.3070
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K043578)

Show all (12)

Other devices from Alpha Ai Co., Ltd.

See all devices from Alpha Ai Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date
Other properties (9)
  • Sterile: 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

Sources (1)

  • FDA UDI 5451290a-e1bc-4b17-8d79-bef9160e1699 35 fields · synced 23 Oct 2026