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EIT TLIF Impactor TET30201

by EIT Emerging Implant Technologies GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

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 Number04260397087657 UDI-DI Date5 Jan 2018ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1323-2022 FDA Class II initiated 20 May 2022
    • Ongoing Z-1324-2022 FDA Class II initiated 20 May 2022

    Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EIT TLIF Impactor
Generic Name
Orthopaedic implant impactor, reusable
Model / Reference
TET30201
Primary DI / UDI-DI
04260397087657
510(k) Number
FDA Product Code
MAX
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K170503)

Show all (12)

Other devices from EIT Emerging Implant Technologies GmbH

See all devices from EIT Emerging Implant Technologies GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: 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