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Wellgraft PE II

by Gwowei Technology Co., Ltd.

510(k) K072170

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 NumberK072170 Date4 Apr 2008ClearedStatusActive

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  • Withdrawn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
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Wellgraft PE II is a Resorbable Bone Void Filler (21 CFR 888.3045), designed to fill and support bone defects during orthopedic procedures. It is composed of a resorbable material intended to gradually integrate with natural bone tissue while maintaining structural integrity during the healing process.

This device is supplied as a sterile, single-use product for surgical applications in orthopedic settings. It is classified under FDA product code MQV and has received Traditional 510(k) clearance as substantially equivalent to a predicate device. Storage and handling must comply with standard surgical instrument protocols to ensure sterility and efficacy.

Other devices from Gwowei Technology Co., Ltd.

Questions

AI-generated answers, 19 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 Wellgraft PE II used for in orthopedic procedures?

    The Wellgraft PE II is a resorbable bone void filler designed to fill and support bone defects during orthopedic procedures, gradually integrating with natural bone tissue while maintaining structural integrity during healing.

  • How is the Wellgraft PE II supplied and what are its handling requirements?

    The device is supplied as a sterile, single-use product for surgical applications in orthopedic settings. Storage and handling must comply with standard surgical instrument protocols to ensure sterility and efficacy.

  • What is the composition and resorption characteristics of the Wellgraft PE II?

    The Wellgraft PE II is composed of a resorbable material that is designed to gradually integrate with natural bone tissue while maintaining structural integrity throughout the healing process.

  • What regulatory clearance has the Wellgraft PE II received?

    The Wellgraft PE II has received Traditional 510(k) clearance as substantially equivalent to a predicate device, classified under FDA product code MQV.