Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OsteoBridge™ IDSF System

K-Number: K181026 · 2018-10-17

ApplicantMerete GmbH
Decision Date2018-10-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoBridge™ IDSF System is the device name listed in this FDA 510(k) record. The listed applicant is Merete GmbH. It received FDA 510(k) clearance on 2018-10-17 under 510(k) number K181026. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoBridge™ IDSF System?

OsteoBridge™ IDSF System is a medical device that received FDA 510(k) clearance on 2018-10-17. The listed applicant is Merete GmbH. The 510(k) number is K181026.

When did OsteoBridge™ IDSF System receive FDA 510(k) clearance?

OsteoBridge™ IDSF System received FDA 510(k) clearance on 2018-10-17, under 510(k) number K181026.

Who is the listed applicant for OsteoBridge™ IDSF System?

The FDA 510(k) record lists Merete GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoBridge™ IDSF System?

The FDA product code for OsteoBridge™ IDSF System is HSB.

Other records listing Merete GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172213MECRON Cannulated Screw System

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑