IMPACT SUTURE ANCHOR. MODEL 433510


Device Classification Name

screw, fixation, bone

510(k) Number K030388
Device Name IMPACT SUTURE ANCHOR. MODEL 433510
Applicant
BIONX IMPLANTS, LTD.
hermiankatu 6-8 l
tampere, 

FI

fin-33720

Applicant Contact tuija annala
Correspondent
BIONX IMPLANTS, LTD.
hermiankatu 6-8 l
tampere, 

FI

fin-33720

Correspodent Contact tuija annala
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 02/05/2003
Decision Date 04/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No