TIGER DISCECTOMY DEVICE


Device Classification Name

arthroscope

510(k) Number K081240
Device Name TIGER DISCECTOMY DEVICE
Applicant
SPINAL DEVICES, LLC
13540 guild ave
apple valley, 
MN 
55124

Applicant Contact richard jansen
Correspondent
SPINAL DEVICES, LLC
13540 guild ave
apple valley, 
MN 
55124

Correspodent Contact richard jansen
Regulation Number 888.1100
Classification Product Code
HRX  
Date Received 05/01/2008
Decision Date 02/27/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No