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Cancellous Screw Long Thread Diameter 6.5MM

by Orthopedic Systems, Inc.

510(k) K895219

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 NumberK895219 Date12 Sep 1989ClearedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

A cancellous screw long thread diameter 6.5mm is an orthopedic fixation device designed for use in cancellous (spongy) bone tissue, such as that found at the ends of long bones including the femur and tibia. It features a long thread design to provide secure anchorage in low-density bone.

The device is supplied in various lengths and is intended for use in orthopedic trauma procedures. It is manufactured from stainless steel 316L or titanium and requires a 3.2mm drill bit for insertion. The device received FDA 510(k) clearance under K895219 and is classified under product code HWC with advisory committee designation OR (Orthopedic).

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Questions

AI-generated answers, 25 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 Cancellous Screw Long Thread 6.5mm used for?

    It is designed for use in cancellous (spongy) bone tissue, such as at the ends of long bones like the femur and tibia, where its long thread provides secure anchorage in low-density bone during orthopedic trauma procedures.

  • How is the Cancellous Screw Long Thread 6.5mm supplied and what sizes are available?

    The device is supplied in various lengths to accommodate different surgical needs, though specific length options are not detailed in the provided data; it has a fixed diameter of 6.5mm and requires a 3.2mm drill bit for insertion.

  • What materials is the Cancellous Screw Long Thread 6.5mm made from and is it reusable?

    It is manufactured from either stainless steel 316L or titanium, materials chosen for biocompatibility and strength; as an implantable fixation device, it is intended for single-use only and should not be reused after implantation.