NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K121392
Device Name NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

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

Correspodent Contact lindy knisely
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   LWJ   MEH  
Date Received 05/09/2012
Decision Date 01/16/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No