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)

ORTHOSTAT

K-Number: K091121 · 2009-04-28

ApplicantOrthocon, Inc.
Decision Date2009-04-28
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

ORTHOSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2009-04-28 under 510(k) number K091121. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSTAT?

ORTHOSTAT is a medical device that received FDA 510(k) clearance on 2009-04-28. The listed applicant is Orthocon, Inc.. The 510(k) number is K091121.

When did ORTHOSTAT receive FDA 510(k) clearance?

ORTHOSTAT received FDA 510(k) clearance on 2009-04-28, under 510(k) number K091121.

Who is the listed applicant for ORTHOSTAT?

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

What is the FDA product code for ORTHOSTAT?

The FDA product code for ORTHOSTAT is MTJ.

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 Orthocon, Inc. 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.

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)K261265Permatage XT Settable Bone PuttyK261439Permatage Flowable, Settable Hemostatic Bone PasteK253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)K253732Permatage Flowable, Settable Bone PasteK253854MONTAGE XT Cranial Cement

View all 33 devices →

Related Devices (Code: MTJ)

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.

K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.K200452Meril-BonewaxM/s. Meril Endo Surgery Private Limited.

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.

↑