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DDS Spinal System

by Encore Orthopedics, Inc.

510(k) K960107

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)SN Traditional NumberK960107 Date3 May 1996DecidedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 23 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 DDS Spinal System is an orthopedic device used in spinal procedures. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The system is supplied by Encore Orthopedics, Inc. and is intended for use in orthopedic spinal applications as indicated by its regulatory classification. It is not sterile, single-use, or MRI safe unless otherwise specified in labeling, and no specific sizes or storage conditions are provided in the data.

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