Skip to content

Aequalis™ Adjustable Reversed 6401035

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 Number00846832059959 UDI-DI Date22 Sep 2015ListedStatusListed 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  • Withdrawn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
Aequalis™ Adjustable Reversed
Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
6401035
Primary DI / UDI-DI
00846832059959
FDA Product Code
KWT, HSD, KWS
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class II
Regulation Number
888.3650, 888.3690, 888.3660
GUDID distribution status
Not in Commercial Distribution
Size
Length — 35 Millimeter

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No