PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)


the company

Device Classification Name

cerclage, fixation

510(k) Number K000694
Device Name PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
Original Applicant
PECTOFIX, INC.
481 memorial pkwy.
metuchen, 
NJ 
08840

Original Contact eric bannon
Regulation Number 888.3010
Classification Product Code
JDQ  
Date Received 03/01/2000
Decision Date 05/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No