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)

MARK I & II TOTAL KNEE REPLACE. SYS

K-Number: K830726 · 1983-06-22

ApplicantAdvanced Biosearch Assn.
Decision Date1983-06-22
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MARK I & II TOTAL KNEE REPLACE. SYS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biosearch Assn.. It received FDA 510(k) clearance on 1983-06-22 under 510(k) number K830726. The device is classified under product code MBV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK I & II TOTAL KNEE REPLACE. SYS?

MARK I & II TOTAL KNEE REPLACE. SYS is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K830726.

When did MARK I & II TOTAL KNEE REPLACE. SYS receive FDA 510(k) clearance?

MARK I & II TOTAL KNEE REPLACE. SYS received FDA 510(k) clearance on 1983-06-22, under 510(k) number K830726.

Who is the listed applicant for MARK I & II TOTAL KNEE REPLACE. SYS?

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

What is the FDA product code for MARK I & II TOTAL KNEE REPLACE. SYS?

The FDA product code for MARK I & II TOTAL KNEE REPLACE. SYS is MBV.

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 Biosearch Assn. 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.

K905514AUTOGENESIS(TM) AUTOMATORK883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.K854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEMK855030CHAMPY BONE PLATES & BONE SCREWSK855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE PK853916P.M. HIP-FEMORAL PROSTHESIS

View all 22 devices →

Related Devices (Code: MBV)

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.

K010212OFFSET TIBIAL TRAYBiomet, Inc.K884824TRICON-M TOTAL KNEE SYSTEMRichards Medical Co., Inc.K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.K853730FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.K833200TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.K831441POROCOAT FREEMAN/SAMUELSON TOTAL KNEEDepuy, 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.

↑