PLEXUR-P


Device Classification Name

filler, bone void, calcium compound

510(k) Number K080511
Device Name PLEXUR-P
Applicant
OSTEOTECH, INC.
51 james way
eatontown, 
NJ 
07724

Applicant Contact chris talbot
Correspondent
OSTEOTECH, INC.
51 james way
eatontown, 
NJ 
07724

Correspodent Contact chris talbot
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 02/25/2008
Decision Date 04/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No