PLLA, HA SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K080358
Device Name PLLA, HA SCREW
Applicant
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact deana boushell
Correspondent
SMITH & NEPHEW INC., ENDOSCOPY DIV.
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact deana boushell
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 02/11/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls