TITANIUM LOW PROFILE SCREWS


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K991807
Device Name TITANIUM LOW PROFILE SCREWS
Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia sandborn beres
Correspondent
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia sandborn beres
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 05/26/1999
Decision Date 07/08/1999
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