FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE— 510(k) K873429

Name: FDA 510(k) clearance K873429
Creator: U.S. Food and Drug Administration
Published: 1987-10-28

Substantially Equivalent

Protek, Inc.

FDA 510(k) clearance K873429 for FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE, Substantially Equivalent on 1987-10-28. Applicant: Protek, Inc.. Device class: 2.

Clearance details

Applicant: Protek, Inc.
Product code: Code MBV
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1987-08-25
Decision date: 1987-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBV

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K833200 — TRICON M TOTAL KNEE SYSTEM1983-11-29
K831441 — POROCOAT FREEMAN/SAMUELSON TOTAL KNEE1983-09-01

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K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR1989-07-19
K883794 — RESUBMITTED CLW ACETABULAR CUP W/SULMESH1989-05-26
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