Cleared Traditional

SURGICAL DYNAMICS SPINAL RETRACTOR

K002008 · United States Surgical, A Division of Tyco Healthc · Orthopedic

Aug 2000

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K002008 is an FDA 510(k) clearance for the SURGICAL DYNAMICS SPINAL RETRACTOR, a Arthroscope (Class II — Special Controls, product code HRX), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on August 16, 2000, 44 days after receiving the submission on July 3, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K002008 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2000
Decision Date	August 16, 2000
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).