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)

OSSTELL ISQ IMPLANT STABILITY METER

K-Number: K082523 · 2008-09-26

ApplicantOsstell AB
Decision Date2008-09-26
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSTELL ISQ IMPLANT STABILITY METER is the device name listed in this FDA 510(k) record. The listed applicant is Osstell AB. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K082523. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSTELL ISQ IMPLANT STABILITY METER?

OSSTELL ISQ IMPLANT STABILITY METER is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is Osstell AB. The 510(k) number is K082523.

When did OSSTELL ISQ IMPLANT STABILITY METER receive FDA 510(k) clearance?

OSSTELL ISQ IMPLANT STABILITY METER received FDA 510(k) clearance on 2008-09-26, under 510(k) number K082523.

Who is the listed applicant for OSSTELL ISQ IMPLANT STABILITY METER?

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

What is the FDA product code for OSSTELL ISQ IMPLANT STABILITY METER?

The FDA product code for OSSTELL ISQ IMPLANT STABILITY METER is EKX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osstell AB 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.

K261987Reusable SmartPegK181888Osstell Beacon

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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.

↑