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4CIS Dolphin Tlif Cage System Aisp-2031-3609

by Solco Biomedical Company India Private Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00840185322043 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  • Withdrawn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

Specification

GUDID

Trade Name
4CIS Dolphin Tlif Cage System
Generic Name
Metallic spinal interbody fusion cage
Model / Ref / Catalog
AISP-2031-3609, 2031-3609
Primary DI / UDI-DI
00840185322043
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 — 4 degree
Length — 36 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