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)

CERETENE SOLUBLE IMPLANT MATERIAL

K-Number: K103047 · 2011-01-05

ApplicantCeremed , Inc.
Decision Date2011-01-05
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CERETENE SOLUBLE IMPLANT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2011-01-05 under 510(k) number K103047. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERETENE SOLUBLE IMPLANT MATERIAL?

CERETENE SOLUBLE IMPLANT MATERIAL is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Ceremed , Inc.. The 510(k) number is K103047.

When did CERETENE SOLUBLE IMPLANT MATERIAL receive FDA 510(k) clearance?

CERETENE SOLUBLE IMPLANT MATERIAL received FDA 510(k) clearance on 2011-01-05, under 510(k) number K103047.

Who is the listed applicant for CERETENE SOLUBLE IMPLANT MATERIAL?

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 CERETENE SOLUBLE IMPLANT MATERIAL?

The FDA product code for CERETENE SOLUBLE IMPLANT MATERIAL is KHJ.

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 MATERIALK102071OSTENE CT, AOC CT, OSTEOTENE, CERETENE

View all 19 devices →

Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.

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.

↑