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)

OTI UNICONDULAR INTERPOSITIONAL SPACER

K-Number: K022779 · 2002-11-20

ApplicantOsteoimplant Technology, Inc.
Decision Date2002-11-20
Product CodeHSH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI UNICONDULAR INTERPOSITIONAL SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Osteoimplant Technology, Inc.. It received FDA 510(k) clearance on 2002-11-20 under 510(k) number K022779. The device is classified under product code HSH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTI UNICONDULAR INTERPOSITIONAL SPACER?

OTI UNICONDULAR INTERPOSITIONAL SPACER is a medical device that received FDA 510(k) clearance on 2002-11-20. The listed applicant is Osteoimplant Technology, Inc.. The 510(k) number is K022779.

When did OTI UNICONDULAR INTERPOSITIONAL SPACER receive FDA 510(k) clearance?

OTI UNICONDULAR INTERPOSITIONAL SPACER received FDA 510(k) clearance on 2002-11-20, under 510(k) number K022779.

Who is the listed applicant for OTI UNICONDULAR INTERPOSITIONAL SPACER?

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

What is the FDA product code for OTI UNICONDULAR INTERPOSITIONAL SPACER?

The FDA product code for OTI UNICONDULAR INTERPOSITIONAL SPACER is HSH.

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 Osteoimplant Technology, 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.

K040685Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATEDK041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK040225OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMK032729Z-SERIES MODULAR TOTAL HIP SYSTEMK030608OTI BONE CEMENT PLUGK021822R120 MODULAR TOTAL HIP SYSTEM

View all 21 devices →

Related Devices (Code: HSH)

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.

K073233ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTSAdvanced Bio-Surfaces, Inc.K053094ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056Advanced Bio-Surfaces, Inc.K033242KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)Imaging Therapeutics, Inc.K003269UNICONDYLAR INTERPOSITIONAL SPACERSulzer Orthopedics, 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.

↑