KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT


Device Classification Name

prosthesis, elbow, hemi-, radial, polymer

510(k) Number K030237
Device Name KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
Original Applicant
KAPP SURGICAL INSTRUMENT, INC.
4919 warrensville center rd.
cleveland, 
OH 
44128

Original Contact albert santilli
Regulation Number 888.3170
Classification Product Code
KWI  
Date Received 01/23/2003
Decision Date 08/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No