PLLA PIN


Device Classification Name

pin, fixation, smooth

510(k) Number K010983
Device Name PLLA PIN
Original Applicant
BIONX IMPLANTS, INC.
hermiankatu 6-8 l
tampere, 

FI

fin-33720

Original Contact tuija annala
Regulation Number 888.3040
Classification Product Code
HTY  
Date Received 04/02/2001
Decision Date 06/13/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No