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KAPSS Spinal System

by Robert Reid, Inc.

510(k) K093833

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 NumberK093833 Date15 Oct 2010ClearedStatusActive

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  • Withdrawn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, 19 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 KAPSS Spinal System is a posterior spinal fixation construct designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. It consists of longitudinal rods, anchors (screws and hooks), interconnection components (rod-to-rod and anchor-to- and anchor-to-rod connectors), and fasteners in a variety of sizes to accommodate differing anatomic requirements.

The system is used by surgeons in clinical settings for posterior pedicle fixation in skeletally mature patients. It is supplied as a non-sterile, reusable device requiring cleaning and sterilization prior to use. The device received FDA 510(k) clearance (K093833) and is classified under product code MNI with advisory committee review in Orthopedics (OR).

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Questions

AI-generated answers, 19 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 KAPSS Spinal System intended for?

    The KAPSS Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion, specifically for posterior pedicle fixation in skeletally mature patients.

  • How is the KAPSS Spinal System supplied and prepared for use?

    The KAPSS Spinal System is supplied as a non-sterile, reusable device that requires cleaning and sterilization prior to each use in clinical settings.

  • What regulatory pathway was used for the KAPSS Spinal System?

    The KAPSS Spinal System received FDA 510(k) clearance under submission number K093833, with a traditional clearance type and a substantially equivalent decision.

  • What components are included in the KAPSS Spinal System?

    The system consists of longitudinal rods, anchors (screws and hooks), interconnection components (rod-to-rod and anchor-to-rod connectors), and fasteners in various sizes to accommodate different anatomic requirements.

  • Under what product code and advisory committee review was the KAPSS Spinal System classified?

    The KAPSS Spinal System is classified under product code MNI and underwent advisory committee review in Orthopedics (OR).