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Prelude Pf Trial Remover 110004169

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00880304567252 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1318-2016 FDA Class II initiated 9 Mar 2016

    Inadequate design control.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Prelude Pf Trial Remover
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable
Model / Ref / Catalog
110004169
Primary DI / UDI-DI
00880304567252
510(k) Number
FDA Product Code
KRR
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable
Device Class
Class II
Regulation Number
888.3540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Cleared under the same submission (K143543)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

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