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Kyphon HV-R Bone Cement

by Medtronic, Inc.

510(k) K160983

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 NumberK160983 Date24 Aug 2016ClearedStatusActive

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  • Withdrawn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
NDN
Device class
Class II
Regulation
21 CFR Part 888.3027
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, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Kyphon HV-R Bone Cement is a high-viscosity radiopaque PMMA cement with augmented barium particles, designed for use in vertebral augmentation procedures. It is used in the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions through kyphoplasty or vertebroplasty procedures.

The cement is supplied as a sterile, single-use device and is not for MRI use. It is regulated under FDA 510(k) clearance with product code NDN and is classified as a Class II medical device. The device is stored according to manufacturer specifications and is authorized for use in the United States.

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