INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY


Device Classification Name

arthroscope

510(k) Number K121482
Device Name INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
Applicant
THEKEN SPINE LLC
1153 medina rd.
medina, 
OH 
44256 -0000

Applicant Contact dale davison
Correspondent
THEKEN SPINE LLC
1153 medina rd.
medina, 
OH 
44256 -0000

Correspodent Contact dale davison
Regulation Number 888.1100
Classification Product Code
HRX  
Subsequent Product Code
HAE  
Date Received 05/18/2012
Decision Date 08/28/2012
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