EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K080408
Device Name EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
2444 205th street, unit 5
torrance, 
CA 
90501

Applicant Contact paul doner
Correspondent
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
2444 205th street, unit 5
torrance, 
CA 
90501

Correspodent Contact paul doner
Regulation Number 888.3030
Classification Product Code
KTT  
Subsequent Product Codes
JDW   JEC  
Date Received 02/14/2008
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No