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FDA 510(k)

ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056

K-Number: K053094 · 2006-02-06

ApplicantAdvanced Bio-Surfaces, Inc.
Decision Date2006-02-06
Product CodeHSH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Bio-Surfaces, Inc.. It received FDA 510(k) clearance on 2006-02-06 under 510(k) number K053094. 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 ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056?

ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 is a medical device that received FDA 510(k) clearance on 2006-02-06. The listed applicant is Advanced Bio-Surfaces, Inc.. The 510(k) number is K053094.

When did ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 receive FDA 510(k) clearance?

ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 received FDA 510(k) clearance on 2006-02-06, under 510(k) number K053094.

Who is the listed applicant for ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056?

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

What is the FDA product code for ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056?

The FDA product code for ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 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 Advanced Bio-Surfaces, 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.

K073233ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS

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.K033242KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)Imaging Therapeutics, Inc.K022779OTI UNICONDULAR INTERPOSITIONAL SPACEROsteoimplant Technology, Inc.K003269UNICONDYLAR INTERPOSITIONAL SPACERSulzer Orthopedics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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