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EIT PLIF Distractor PET60803

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

Recall on shared 510(k) K170503; other models may be affected

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 Number04260557775875 UDI-DI Date27 Sep 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 on shared 510(k) K170503
    • Ongoing Z-1324-2022 FDA Class II initiated 20 May 2022 on shared 510(k) K170503

    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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EIT PLIF Distractor
Generic Name
Orthopaedic surgical distractor, internal
Model / Reference
PET60803
Primary DI / UDI-DI
04260557775875
510(k) Number
FDA Product Code
LXH
GMDN Term
Orthopaedic surgical distractor, internal
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical distractor, internal

Cleared under the same submission (K170503)

Show all (12)

Other devices from EIT Emerging Implant Technologies GmbH

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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