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)

KRYPTONITE BONE CEMENT

K-Number: K091382 · 2009-11-16

ApplicantDoctors Research Group, Inc.
Decision Date2009-11-16
Product CodeGXP
Advisory CommitteeNE
DecisionUnknown

Device Summary

KRYPTONITE BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Doctors Research Group, Inc.. It received FDA 510(k) clearance on 2009-11-16 under 510(k) number K091382. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the KRYPTONITE BONE CEMENT?

KRYPTONITE BONE CEMENT is a medical device that received FDA 510(k) clearance on 2009-11-16. The listed applicant is Doctors Research Group, Inc.. The 510(k) number is K091382.

When did KRYPTONITE BONE CEMENT receive FDA 510(k) clearance?

KRYPTONITE BONE CEMENT received FDA 510(k) clearance on 2009-11-16, under 510(k) number K091382.

Who is the listed applicant for KRYPTONITE BONE CEMENT?

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

What is the FDA product code for KRYPTONITE BONE CEMENT?

The FDA product code for KRYPTONITE BONE CEMENT is GXP.

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

Related Devices (Code: GXP)

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.

K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.K261265Permatage XT Settable Bone PuttyOrthocon, Inc.K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.K253854MONTAGE XT Cranial CementOrthocon, Inc.K241027Permatage Settable Bone PuttyOrthocon, Inc.K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, 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.

↑