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Palamed

by Heraeus Medical GmbH Technology

510(k) K030904

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 · Abbreviated NumberK030904 Date23 Sep 2003ClearedStatusActive

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  • Withdrawn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
LOD
Device Class
Class II
Regulation
21 CFR Part 888.3027
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.

Palamed is a bone cement device classified as a Class II medical device under FDA regulation number 888.3027. It is substantially equivalent to a legally marketed predicate device as determined by FDA 510(k) clearance K030904.

The device is supplied by Heraeus Medical GmbH Technology and is intended for use in orthopedic applications. It is provided in a non-sterile, reusable format and is not indicated for MRI safety; specific sizes, storage conditions, and single-use status are not detailed in the supplied data.

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 PALAMED device intended for?

    The PALAMED device is a bone cement intended for use in orthopedic applications, as stated in its description. It is classified as a Class II medical device under FDA regulation number 888.3027 and is substantially equivalent to a predicate device cleared via 510(k) K030904. The device is not indicated for MRI safety, and no specific clinical indications beyond orthopedic use are provided in the data.

  • How is the PALAMED device supplied, and is it sterile or reusable?

    The PALAMED device is supplied in a non-sterile, reusable format, as explicitly stated in the description. It is not provided sterile, and there is no indication in the data that it is designed for single-use. Users must follow appropriate sterilization protocols prior to each use, as the device is intended for reuse.

  • What regulatory pathway was used for the PALAMED device, and what is its classification?

    The PALAMED device received FDA 510(k) clearance under submission K030904, indicating it is substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under FDA regulation number 888.3027, with product code LOD and advisory committee designation OR (Orthopedic). This classification reflects its risk level and regulatory oversight for orthopedic bone cement applications.