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CAPTIVATE Compression Screws

by Globus Medical, Inc.

510(k) K162825

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162825 Date1 May 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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, 22 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 CAPTIVATE Compression Screws are smooth or threaded metallic bone fixation fasteners used for fracture repair, bone reconstruction, and arthrodesis. They utilize a differential thread pitch design to provide compression across bone interfaces.

These devices are supplied non-sterile and are intended for single-use in orthopedic surgical settings. They are classified as Class II medical devices under FDA regulation 21 CFR 888.3040 with product code HWC and have received FDA 510(k) clearance (K162825) as substantially equivalent to a predicate device.

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