Cleared Traditional

KAMBIN SPINAL INSTRUMENT SET

K853678 · Pilling Co. · General & Plastic Surgery
Sep 1985
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K853678 is an FDA 510(k) clearance for the KAMBIN SPINAL INSTRUMENT SET, a Instrument, Cutting, Orthopedic (Class I — General Controls, product code HTZ), submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on September 24, 1985, 21 days after receiving the submission on September 3, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K853678 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1985
Decision Date September 24, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HTZ — Instrument, Cutting, Orthopedic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800