Skip to content

Smr Reverse Liner

by Lima Corporate S.P.A. 510(k)

Active United States

510(k) K220792

Overview

The Smr Reverse Liner is a prosthesis, shoulder, semi-constrained, metal/polymer, uncemented device. It is classified as a class 2 device. The device is used in orthopedic applications.

The Smr Reverse Liner is supplied with various registration numbers, including 9616671 and 3004748528. It has an FDA 510K authorization and is regulated under regulation number 888.3670. The device is intended for use in a medical setting, specifically in orthopedic procedures.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220792 Date19 May 2022ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBF
Device Class
Class II
Regulation
21 CFR Part 888.3670
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Lima Corporate S.P.A.

See all devices from Lima Corporate S.P.A. →

Questions

  • What is the SMR Reverse Liner used for?

    The SMR Reverse Liner is used in orthopedic applications, specifically for shoulder procedures.

  • Is the SMR Reverse Liner supplied sterile?

    The device data does not specify if the SMR Reverse Liner is supplied sterile, it is recommended to consult the manufacturer's instructions for use.

  • What are the regulatory authorizations for the SMR Reverse Liner?

    The SMR Reverse Liner has an FDA 510K authorization and is regulated under regulation number 888.3670.

  • What type of device is the SMR Reverse Liner classified as?

    The SMR Reverse Liner is classified as a class 2 device.