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FDA 510(k)

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE

K-Number: K873429 · 1987-10-28

ApplicantProtek, Inc.
Decision Date1987-10-28
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1987-10-28 under 510(k) number K873429. 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 FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE?

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE is a medical device that received FDA 510(k) clearance on 1987-10-28. The listed applicant is Protek, Inc.. The 510(k) number is K873429.

When did FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE receive FDA 510(k) clearance?

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE received FDA 510(k) clearance on 1987-10-28, under 510(k) number K873429.

Who is the listed applicant for FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE?

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

What is the FDA product code for FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE?

The FDA product code for FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE is MBV.

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Other records listing Protek, 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.

K893785ARC-2F ACETABULAR CUPK893959P.S.A. FEMORAL HIP PROSTHESISK892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURK883794RESUBMITTED CLW ACETABULAR CUP W/SULMESHK884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICK884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

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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.K853730FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.K833200TRICON M TOTAL KNEE SYSTEMRichards Medical Co., Inc.K831441POROCOAT FREEMAN/SAMUELSON TOTAL KNEEDepuy, Inc.K832302MARK I TOTAL KNEE SYS. ARTHROPLASTYAdvanced Biosearch Assn.

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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