NOVATION LPI PRIME FEMORAL STEM


Device Classification Name

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

510(k) Number K121684
Device Name NOVATION LPI PRIME FEMORAL STEM
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Applicant Contact vladislava zaitseva
Correspondent
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Correspodent Contact vladislava zaitseva
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO  
Date Received 06/07/2012
Decision Date 10/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No