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GENflex2 Total Knee System SC3916-2.5-13

by Globus Medical, Inc.

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 Number10840843124023 UDI-DI Date31 Jan 2018ListedStatusListed 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  • Withdrawn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
GENflex2 Total Knee System
Generic Name
Tibial insert
Model / Reference
SC3916-2.5-13
Primary DI / UDI-DI
10840843124023
FDA Product Code
OIY
GMDN Term
Tibial insert
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insert

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No