Cleared Traditional

ASPACH 65,000 (MODIFICATION)

K955084 · The Anspach Effort, Inc. · Orthopedic

Jan 1996

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K955084 is an FDA 510(k) clearance for the ASPACH 65,000 (MODIFICATION), a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 17, 1996, 90 days after receiving the submission on October 19, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K955084 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1995
Decision Date	January 17, 1996
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

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