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Leaplaza Frame

by Spintech, Inc.

510(k) K922238

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922238 Date23 Dec 1992ClearedStatusActive

Official records

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  • Withdrawn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
KWP
Device class
Class II
Regulation
21 CFR Part 888.3050
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.

The Leaplaza Frame is an orthopedic external fixation device designed to stabilize and support long bone fractures. It employs a modular frame system with pins and rods to maintain proper alignment during the healing process, facilitating external skeletal fixation for complex orthopedic cases.

This device is supplied as a reusable system, intended for use in clinical settings such as hospitals and orthopedic clinics. It is not sterile at the time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The Leaplaza Frame holds FDA 510(k) clearance under K922238, classified under product code KWP, and was reviewed by the Orthopedic (OR) Advisory Committee in 1992.

Similar devices

Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).

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