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

by Interpore Cross Intl.

510(k) K993808

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 · Special NumberK993808 Date6 Dec 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  • Withdrawn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
MNH
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Synergy Integral Screws are orthopedic devices used for fixation purposes in surgical procedures. These screws are available in multiple model numbers as specified in the product identification.

The device is supplied as a single-use or reusable product, though specific sterility and storage details are not provided in the data. The Synergy Integral Screws have FDA 510(k) clearance with K993808 and are classified under product code MNH for orthopedic applications.

Other devices from Interpore Cross Intl.

See all devices from Interpore Cross Intl. →

Questions

AI-generated answers, 27 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 are Synergy Integral Screws used for?

    Synergy Integral Screws are orthopedic devices designed for fixation purposes in surgical procedures. They are available in multiple model numbers (2161, 2162, 2163, 2164, 2165, 2166, 2167, 2168, 2169, 2210, 2211, 2212, 2215, 2216, 2217, 2220) to accommodate various surgical needs.

  • Are Synergy Integral Screws single-use or reusable?

    The Synergy Integral Screws are supplied as either single-use or reusable products, though specific details about sterility and storage requirements are not provided in the available device data.

  • What regulatory status do Synergy Integral Screws have?

    Synergy Integral Screws have FDA 510(k) clearance with K993808 and are classified under product code MNH for orthopedic applications. They were determined to be substantially equivalent to predicate devices.

  • How many models of Synergy Integral Screws are available?

    There are 16 different models of Synergy Integral Screws available, with model numbers ranging from 2161 to 2220 (2161, 2162, 2163, 2164, 2165, 2166, 2167, 2168, 2169, 2210, 2211, 2212, 2215, 2216, 2217, 2220).