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Orthovis Preoperative Plan

by Custom Orthopaedic Solutions

510(k) K133367

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133367 Date20 Dec 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orthovis Preoperative Plan is a preoperative plan document generated through the Orthovis software platform. It is designed to facilitate accurate preoperative planning and the intraoperative placement of the glenoid component during total shoulder replacement procedures.

This device is authorized under FDA 510(k) clearance K133367. It provides surgeons with an interactive, patient-specific view to assist in surgical planning.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Orthovis Preoperative Plan?

    This device is designed to facilitate accurate preoperative planning for total shoulder replacement procedures. It provides surgeons with an interactive, patient-specific view to assist in the precise intraoperative placement of the glenoid component.

  • How is the Orthovis Preoperative Plan generated?

    The plan is generated through the Orthovis software platform. It utilizes patient-specific data to create an interactive view that surgeons use to prepare for shoulder replacement surgery.

  • What is the regulatory status of this device?

    The Orthovis Preoperative Plan is authorized under FDA 510(k) clearance K133367. It was determined to be substantially equivalent to existing devices through a traditional clearance process.