CAP PLUS, EQUIVABONE, CAP/DBM


Device Classification Name

filler, bone void, osteoinduction (w/o human growth factor)

510(k) Number K080329
Device Name CAP PLUS, EQUIVABONE, CAP/DBM
Applicant
ETEX CORP.
38 sidney st., 3flr
the clark bldg.
cambridge, 
MA 
02139

Applicant Contact pamela w adams
Correspondent
ETEX CORP.
38 sidney st., 3flr
the clark bldg.
cambridge, 
MA 
02139

Correspodent Contact pamela w adams
Regulation Number 888.3045
Classification Product Code
MBP  
Subsequent Product Code
MQV  
Date Received 02/07/2008
Decision Date 04/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No