2GC HIP/KNEE MODULAR SPACER


Device Classification Name

prosthesis, hip, hemi-, femoral, metal

510(k) Number K112470
Device Name 2GC HIP/KNEE MODULAR SPACER
Applicant
MANDELL HORWITZ CONSULTANTS LLC
2995 steven martin dr
fairfax, 
VA 
22031

Applicant Contact diane m horwitz
Correspondent
MANDELL HORWITZ CONSULTANTS LLC
2995 steven martin dr
fairfax, 
VA 
22031

Correspodent Contact diane m horwitz
Regulation Number 888.3360
Classification Product Code
KWL  
Subsequent Product Codes
JWH   KWY   MBB  
Date Received 08/26/2011
Decision Date 04/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes