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Stabilis AFPK25225

by Tornier, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00846832005116 UDI-DI Date10 Aug 2022ListedStatusListed GUDID: not 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  • Withdrawn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
Stabilis
Generic Name
Orthopaedic implant calibration pin
Model / Ref / Catalog
AFPK25225
Primary DI / UDI-DI
00846832005116
FDA Product Code
LXH
GMDN Term
Orthopaedic implant calibration pin
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 225 Millimeter
Outer Diameter — 2.5 Millimeter

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No