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Synergy Integral Screws, Models, 2161, 2162, 2163, 2164, 2165, 2166, 2167, 2168, 2169, 2210, 2211, 2212, 2215, 2216, 2217, 2220, 2221, 22

by Interpore Cross Intl.

510(k) K992369

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 NumberK992369 Date13 Oct 1999ClearedStatusActive

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  • Withdrawn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
MNI
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Synergy Integral Screws are components of the Synergy Spinal System, which is a posterior and anterior spinal fixation construct. These screws are designed to be used as part of a spinal fixation system to provide stability and support.

The system includes various integral screw models, specifically 2161, 2162, 2163, 2164, 2165, 2166, 2167, 2168, 2169, 2210, 2211, 2212, 2215, 2216, 2217, 2220, 2221, and 22. This device has received FDA 510(k) clearance.

Other devices from Interpore Cross Intl.

See all devices from Interpore Cross Intl. →

Questions

AI-generated answers, 6 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 are the Synergy Integral Screws used for?

    The Synergy Integral Screws are components of the Synergy Spinal System, designed to function as part of a posterior and anterior spinal fixation construct to provide stability and support to the spine.

  • Which models are available for the Synergy Integral Screws?

    The system includes a wide range of integral screw models, specifically models 2161, 2162, 2163, 2164, 2165, 2166, 2167, 2168, 2169, 2210, 2211, 2212, 2215, 2216, 2217, 2220, 2221, and 22.

  • What is the regulatory status of the Synergy Integral Screws?

    The Synergy Integral Screws have received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to legally marketed predicate devices.