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Camber Spine Diagon Oblique Cage

by Camber Spine

510(k) K134038

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 NumberK134038 Date20 Mar 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  • Withdrawn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
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Camber Spine Diagon Oblique Cage is an intervertebral body fusion device designed for use in the lumbar spine. It is indicated for intervertebral body fusion procedures in skeletally mature patients diagnosed with degenerative disc disease at one or two contiguous levels from L2-S1.

This device has received FDA 510(k) clearance. It is intended for patients with discogenic pain and disc degeneration confirmed by history and radiographic studies, including those with up to Grade I spondylolisthesis.

Other devices from Camber Spine

Questions

AI-generated answers, 24 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 intended use of the Camber Spine Diagon Oblique Cage?

    This device is an intervertebral body fusion cage designed for use in the lumbar spine. It is specifically indicated for fusion procedures in skeletally mature patients suffering from degenerative disc disease at one or two contiguous levels between L2 and S1.

  • Which patient conditions are suitable for this fusion device?

    The cage is intended for patients who have confirmed discogenic pain and disc degeneration based on patient history and radiographic studies. It is also indicated for use in patients with up to Grade I spondylolisthesis.

  • Has this device received regulatory clearance?

    Yes, the Camber Spine Diagon Oblique Cage has received FDA 510(k) clearance. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.