Cleared Traditional

GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET

K952543 · Neoligaments, Ltd. · Orthopedic

Jun 1995

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K952543 is an FDA 510(k) clearance for the GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Neoligaments, Ltd. (Leeds, GB). The FDA issued a Cleared decision on June 22, 1995, 35 days after receiving the submission on May 18, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K952543 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1995
Decision Date	June 22, 1995
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820