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FDA 510(k)

MARK I TOTAL KNEE SYS. ARTHROPLASTY

K-Number: K832302 · 1983-08-16

ApplicantAdvanced Biosearch Assn.
Decision Date1983-08-16
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MARK I TOTAL KNEE SYS. ARTHROPLASTY 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 1983-08-16 under 510(k) number K832302. 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 TOTAL KNEE SYS. ARTHROPLASTY?

MARK I TOTAL KNEE SYS. ARTHROPLASTY is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K832302.

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

MARK I TOTAL KNEE SYS. ARTHROPLASTY received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832302.

Who is the listed applicant for MARK I TOTAL KNEE SYS. ARTHROPLASTY?

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 TOTAL KNEE SYS. ARTHROPLASTY?

The FDA product code for MARK I TOTAL KNEE SYS. ARTHROPLASTY is MBV.

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Other records listing Advanced Biosearch Assn. as applicant

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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

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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.

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