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OsteoCentric Integrated Hip Fastener System

by Osteocentric Technologies D.B.A. Osteocentric Trauma

510(k) K210247

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 · Traditional NumberK210247 Date30 Apr 2021ClearedStatusActive

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  • Withdrawn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
JDO
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 OsteoCentric Integrated Hip Fastener System is a modular orthopedic implant system consisting of stainless steel plates and screws. It is used by orthopedic surgeons in a clinical/surgical setting for the internal fixation of femoral neck fractures.

The device is supplied as a single-use implant and is intended for use in internal fixation of femoral neck fractures. It is not sterilized and must be sterilized prior to use. The device is not MRI safe.