NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL


Device Classification Name

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

510(k) Number K111572
Device Name NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
Applicant
SERF
1001 oakwood blvd.
round rock, 
TX 
78681

Applicant Contact j.d. webb
Correspondent
SERF
1001 oakwood blvd.
round rock, 
TX 
78681

Correspodent Contact j.d. webb
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received 06/06/2011
Decision Date 08/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No