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)

OSTENE CT, AOC CT, OSTEOTENE, CERETENE

K-Number: K102071 · 2010-10-08

ApplicantCeremed , Inc.
Decision Date2010-10-08
Product CodeMTJ
DecisionSubstantially Equivalent

Device Summary

OSTENE CT, AOC CT, OSTEOTENE, CERETENE is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2010-10-08 under 510(k) number K102071. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTENE CT, AOC CT, OSTEOTENE, CERETENE?

OSTENE CT, AOC CT, OSTEOTENE, CERETENE is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is Ceremed , Inc.. The 510(k) number is K102071.

When did OSTENE CT, AOC CT, OSTEOTENE, CERETENE receive FDA 510(k) clearance?

OSTENE CT, AOC CT, OSTEOTENE, CERETENE received FDA 510(k) clearance on 2010-10-08, under 510(k) number K102071.

Who is the listed applicant for OSTENE CT, AOC CT, OSTEOTENE, CERETENE?

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

What is the FDA product code for OSTENE CT, AOC CT, OSTEOTENE, CERETENE?

The FDA product code for OSTENE CT, AOC CT, OSTEOTENE, CERETENE 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 Ceremed , 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.

K161446Biopor Porous Polyethylene ImplantsK160988Biopor, AOC Porous Polyethylene, CereporK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAIK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINK120220ADAPTAIN SOLUBLE IMPLANT MATERIALK103047CERETENE SOLUBLE IMPLANT MATERIAL

View all 19 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.

↑