MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR


Device Classification Name

screw, fixation, bone

510(k) Number K081428
Device Name MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
Applicant
BIOCOMPOSITES LTD.
keele science park
keele, staffordshire, 

GB

st5 5nl

Applicant Contact simon fitzer
Correspondent
BIOCOMPOSITES LTD.
keele science park
keele, staffordshire, 

GB

st5 5nl

Correspodent Contact simon fitzer
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
JDR  
Date Received 05/21/2008
Decision Date 06/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No