REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS


definition

Device Classification Name

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

510(k) Number K002747
Device Name REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Original Contact david henley
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received 09/05/2000
Decision Date 12/15/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Abbreviated
Reviewed by Third Party No

Combination Product

No