FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP— 510(k) K853730

Name: FDA 510(k) clearance K853730
Creator: U.S. Food and Drug Administration
Published: 1986-02-18

Substantially Equivalent

Protek, Inc.

FDA 510(k) clearance K853730 for FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP, Substantially Equivalent on 1986-02-18. 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: 1985-09-06
Decision date: 1986-02-18
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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K010212 — OFFSET TIBIAL TRAY2001-02-14
K884824 — TRICON-M TOTAL KNEE SYSTEM1989-11-21
K873429 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE1987-10-28
K833200 — TRICON M TOTAL KNEE SYSTEM1983-11-29
K831441 — POROCOAT FREEMAN/SAMUELSON TOTAL KNEE1983-09-01

More clearances from Protek, Inc.

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K893785 — ARC-2F ACETABULAR CUP1989-08-09
K893959 — P.S.A. FEMORAL HIP PROSTHESIS1989-07-25
K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR1989-07-19
K883794 — RESUBMITTED CLW ACETABULAR CUP W/SULMESH1989-05-26
K884952 — VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC1989-05-10

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