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Osteomedics Resorbable Small Fixation System, Osteosorb

by Osteomedics, Inc.

510(k) K022035

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022035 Date17 Jan 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
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.

The Osteomedics Resorbable Small Fixation System, Osteosorb, is a Plate, Bone (per FDA nomenclature) designed for internal fixation of bone fragments. It is composed of resorbable materials intended to provide temporary structural support during the healing process of skeletal injuries or reconstructive procedures in the midface, craniofacial skeleton, or maxilla.

This system is supplied as a sterile, single-use device and is classified as Class II under FDA regulation 872.4760. It is intended for use in dental and craniofacial surgical settings, with specific model and reference codes listed in the FDA database. The device requires professional handling and adherence to sterile techniques, as outlined in its regulatory submission (510(k) K022035).

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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 types of surgical procedures is the Osteosorb system designed to support during bone healing?

    The Osteosorb system is specifically designed for internal fixation of bone fragments in midface, craniofacial skeleton, or maxilla procedures. It provides temporary structural support during the healing process of skeletal injuries or reconstructive surgeries in these areas, ensuring stability while the bone regenerates.

  • Is the Osteosorb system reusable or intended for single-use only, and how should it be handled?

    The Osteosorb system is supplied as a sterile, single-use device. Due to its resorbable materials and sterile packaging, it must be handled with professional care and strict adherence to sterile techniques to maintain integrity and prevent contamination.

  • What sizes or models are available for the Osteosorb system, and how can I verify compatibility for a specific procedure?

    The Osteosorb system includes multiple model and reference codes (e.g., 3011302692, 1000307073, etc.), as listed in the FDA database. These correspond to different configurations or sizes tailored for specific craniofacial or maxillofacial applications. To verify compatibility, cross-reference the procedure requirements with the manufacturer’s catalog or consult Osteomedics, Inc. for guidance.

  • How should the Osteosorb system be stored to ensure its effectiveness and sterility?

    Since the Osteosorb system is sterile and single-use, it must be stored in its original packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s instructions for shelf-life and storage conditions to preserve sterility and functionality.