MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS


Device Classification Name

prosthesis, shoulder, semi-constrained, metal/polymer cemented

510(k) Number K030344
Device Name MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Original Contact david henley
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 02/03/2003
Decision Date 03/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No