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FDA 510(k)

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP

K-Number: K853730 · 1986-02-18

ApplicantProtek, Inc.
Decision Date1986-02-18
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1986-02-18 under 510(k) number K853730. 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 REP?

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP is a medical device that received FDA 510(k) clearance on 1986-02-18. The listed applicant is Protek, Inc.. The 510(k) number is K853730.

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

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP received FDA 510(k) clearance on 1986-02-18, under 510(k) number K853730.

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

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 REP?

The FDA product code for FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP 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.K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, 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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