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Chesapeake Spinal System

by K2M, Inc. 3 variants

510(k) K133494

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 NumberK133494 Date10 Jun 2014ClearedStatusActive

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  • Withdrawn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
OVD
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Chesapeake Spinal System is a multi-screw construct designed to provide stability to the anterior column of the lumbar spine, reducing the need for supplemental fixation. This system is intended for use in spinal surgery applications.

The Chesapeake Spinal System is supplied by K2M, Inc. and has received FDA 510(k) clearance with the product code OVD. It is available in various models and sizes as specified by the manufacturer.

Other devices from K2M, Inc.

See all devices from K2M, Inc. →

Questions

AI-generated answers, 28 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 Chesapeake Spinal System designed for?

    The Chesapeake Spinal System is a multi-screw construct designed to provide stability to the anterior column of the lumbar spine, reducing the need for supplemental fixation in spinal surgery applications.

  • How is the Chesapeake Spinal System supplied?

    The Chesapeake Spinal System is supplied by K2M, Inc. and is available in various models and sizes as specified by the manufacturer to accommodate different surgical needs.

  • What regulatory clearance has the Chesapeake Spinal System received?

    The Chesapeake Spinal System has received FDA 510(k) clearance with the product code OVD, classified under the Orthopedic advisory committee, with a decision date of 2014-06-10.

  • Is the Chesapeake Spinal System reusable or single-use?

    The device data does not specify whether the Chesapeake Spinal System is designed for single-use or reuse. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocol.