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Verasense

by Orthosensor Inc 104 variants

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 6 Oct 2026. What this means

Overview

A comprehensive electronic medical device for arthroplasty, designed to facilitate assessment of joint function during implantation of prosthesis components. It is available as a left or right version and consists of a transducer pad for insertion between opposing joint surfaces.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816818020280 UDI-DI Date18 Nov 2016ListedStatusListed 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  • Withdrawn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

Generic Name
Arthroplasty force sensor
Model / Ref / Catalog
VERASENSE for Smith & Nephew Legion CR size 3-4, SNN-LGNCR34
Primary DI / UDI-DI
00816818020280
FDA Product Code
ONN
GMDN Term
Arthroplasty force sensor
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
Not in Commercial Distribution

Other devices from Orthosensor Inc

See all devices from Orthosensor Inc →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No