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)

OSTEOMED ORTHODONTIC SCREW SYSTEM

K-Number: K031936 · 2004-01-07

ApplicantOsteomed LP
Decision Date2004-01-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED ORTHODONTIC SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2004-01-07 under 510(k) number K031936. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOMED ORTHODONTIC SCREW SYSTEM?

OSTEOMED ORTHODONTIC SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-07. The listed applicant is Osteomed LP. The 510(k) number is K031936.

When did OSTEOMED ORTHODONTIC SCREW SYSTEM receive FDA 510(k) clearance?

OSTEOMED ORTHODONTIC SCREW SYSTEM received FDA 510(k) clearance on 2004-01-07, under 510(k) number K031936.

Who is the listed applicant for OSTEOMED ORTHODONTIC SCREW SYSTEM?

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

What is the FDA product code for OSTEOMED ORTHODONTIC SCREW SYSTEM?

The FDA product code for OSTEOMED ORTHODONTIC SCREW SYSTEM is DZE.

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 Osteomed LP 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.

K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMK123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORK123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMK120015OSTEOMED WRIST PLATING SYSTEMK111419OSTEOMED HAND FUSION SYSTEMK111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM

View all 27 devices →

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.

↑