M2A 28MM RINGLOC LINER


codes

Device Classification Name

prosthesis, hip, semi-constrained (metal uncemented acetabular component)

510(k) Number K002379
Device Name M2A 28MM RINGLOC LINER
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact michelle l mckinley
Regulation Number 888.3330
Classification Product Code
KWA  
Date Received 08/04/2000
Decision Date 08/31/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No