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Mercury Spinal System

by Spinal Elements, Inc. 6 variants

510(k) K082353

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082353 Date22 Jan 2009ClearedStatusActive

Official records

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  • Withdrawn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
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 25 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 Mercury Spinal System is a posterior thoracolumbar spinal fixation system designed to correct and stabilize the posterior thoraco-lumbosacral spine. It is a titanium rod-based system that offers a collection of instruments and implants, including cannulated and non-cannulated multi-axial pedicle screws.

The Mercury Spinal System is supplied with a range of instruments and implants, including 5.5mm titanium rods. It is a traditional clearance type device, authorized by the FDA under the 510K clearance type, with the decision code SESE. The device is manufactured by Spinal Elements, Inc. and has a product code of NKB.

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