Cleared Traditional

K901692 - DANEK SPINALSCOPE
(FDA 510(k) Clearance)

K901692 · Danek Medical, Inc. · Orthopedic

Feb 1992

Decision

674d

Days

Class 2

Risk

K901692 is an FDA 510(k) clearance for the DANEK SPINALSCOPE. This device is classified as a Arthroscope (Class II — Special Controls, product code HRX).

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on February 14, 1992, 674 days after receiving the submission on April 11, 1990.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.1100. 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)..

Submission Details

510(k) Number	K901692 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 1990
Decision Date	February 14, 1992
Days to Decision	674 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

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).