Cleared Traditional

K832302 - MARK I TOTAL KNEE SYS. ARTHROPLASTY
(FDA 510(k) Clearance)

K832302 · Advanced Biosearch Assn. · Orthopedic

Aug 1983

Decision

33d

Days

Class 2

Risk

K832302 is an FDA 510(k) clearance for the MARK I TOTAL KNEE SYS. ARTHROPLASTY, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code MBV), submitted by Advanced Biosearch Assn. (Walker, US). The FDA issued a Cleared decision on August 16, 1983, 33 days after receiving the submission on July 14, 1983. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K832302 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1983
Decision Date	August 16, 1983
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	MBV — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560