SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS


Device Classification Name

orthosis, spinal pedicle fixation

510(k) Number K112611
Device Name SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
Applicant
SINTEA PLASTEK, LLC
407 lincoln road
suite 10l
miami beach, 
FL 
33139

Applicant Contact danielle wernikowski
Correspondent
SINTEA PLASTEK, LLC
407 lincoln road
suite 10l
miami beach, 
FL 
33139

Correspodent Contact danielle wernikowski
Regulation Number 888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received 09/07/2011
Decision Date 04/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No