SPL CRIMP SYSTEM


codes

Device Classification Name

cerclage, fixation

510(k) Number K002110
Device Name SPL CRIMP SYSTEM
Original Applicant
PIONEER SURGICAL TECHNOLOGY
375 river park circle
marquette, 
MI 
49855 -0627

Original Contact amy h mommaerts
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 07/12/2000
Decision Date 10/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No