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4CIS Dolphin Tlif Cage System Aisp-2030-2514

by Solco Biomedical Company India Private Limited GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840185321022 UDI-DIDate21 Apr 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
4CIS Dolphin Tlif Cage System
Generic Name
Metallic spinal interbody fusion cage
Model / Ref / Catalog
AISP-2030-2514, 2030-2514
Primary DI / UDI-DI
00840185321022
510(k) Number
FDA Product Code
MAX
GMDN Term
Metallic spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Angle — 0 degree
Length — 25 Millimeter

Related devices

Cleared under the same submission (K213653)

Show all (12)

Other devices from Solco Biomedical Company India Private Limited

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (7)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No