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FDA 510(k), K111572, NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
FDA 510(k), K111572, NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
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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
Manufacturer: SERF
Device Classification Name: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Regulation Number: 888.3353
Classification Product Code: LZO
Date Received: 06/06/2011
Decision Date: 08/29/2011
Regulation Medical Specialty: Orthopedic
Device Name: NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
Manufacturer: SERF
Device Classification Name: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Regulation Number: 888.3353
Classification Product Code: LZO
Date Received: 06/06/2011
Decision Date: 08/29/2011
Regulation Medical Specialty: Orthopedic
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