Cleared Traditional

CURVTEK TSR SYSTEM

K972860 · Biolectron, Inc. · Orthopedic

Oct 1997

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K972860 is an FDA 510(k) clearance for the CURVTEK TSR SYSTEM, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Biolectron, Inc. (Hackensack, US). The FDA issued a Cleared decision on October 31, 1997, 88 days after receiving the submission on August 4, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K972860 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 1997
Decision Date	October 31, 1997
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820