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3DP Lumbar Interbody System 1

by Genesys Orthopedics Systems LLC 914 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberM719GA3D1806S0 UDI-DI Date6 Jan 2020ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
3DP Lumbar Interbody System
Generic Name
Metallic spinal fusion cage, non-sterile
Model / Ref / Catalog
1, GA3D-1806S
Primary DI / UDI-DI
M719GA3D1806S0
510(k) Number
FDA Product Code
MAX
GMDN Term
Metallic spinal fusion cage, non-sterile
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Height — 18 Millimeter
Angle — 6 degree

Related devices

Category: Metallic spinal fusion cage, non-sterile

Cleared under the same submission (K182987)

Show all (12)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: 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
  • Manufacturing Date: No