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Metallic Locking Bone Plate and Screw

by Canwell Medical Co., Ltd

510(k) K142943

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 NumberK142943 Date3 Aug 2015ClearedStatusActive

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  • Withdrawn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
HRS
FDA applicant
Canwell Medical Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a metallic locking bone plate and screw system classified under orthopedic fixation devices. It is designed to provide stable internal fixation for fractures, osteotomies, malunions, and nonunions in long bones such as the ulna, radius, humerus, femur, tibia, clavicle, and fibula. The locking mechanism ensures secure alignment and promotes proper bone healing by maintaining rigid fixation during the recovery process.

The device is supplied sterile and intended for single-use applications in orthopedic surgical settings. It is intended for use in adult patients aged 21 and older with normal bone density or osteopenic bone. The system adheres to FDA 510(k) clearance under the traditional review pathway, with a clearance number of K142943. Storage and handling must comply with standard orthopedic surgical protocols to maintain sterility and functionality.

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Questions

AI-generated answers, 1 Oct 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 Canwell Metallic Locking Bone Plate and Screw System?

    This system is designed to provide stable internal fixation for fractures, osteotomies, malunions, and nonunions in long bones such as the ulna, radius, humerus, femur, tibia, clavicle, and fibula. The locking mechanism ensures secure alignment, reducing movement and promoting proper bone healing during recovery.

  • Is this device intended for reuse or single-use applications?

    The Canwell Metallic Locking Bone Plate and Screw System is explicitly intended for single-use applications in orthopedic surgical settings. This ensures sterility and safety for each patient, aligning with standard medical device protocols.

  • What age group and bone density conditions does this device support?

    This system is approved for adult patients aged 21 and older with either normal bone density or osteopenic bone. It is not intended for pediatric use or patients with severe osteoporosis unless clinically indicated by the surgeon.

  • How should the device be stored to maintain sterility and functionality?

    The device must be stored and handled according to standard orthopedic surgical protocols to preserve sterility and functionality. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and following manufacturer guidelines for shelf life.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Canwell Metallic Locking Bone Plate and Screw System underwent a traditional review pathway under the FDA’s 510(k) clearance process, with a clearance number of K142943. The device was determined to be substantially equivalent to a legally marketed predicate.