The following data is part of a premarket notification filed by Serf with the FDA for Novae Sunfit Th Dual Mobility Acetabular Cup Model Sunfit Th (metal-back), Novae E Th Dual Mobility Acetabular Cup Model.
| Device ID | K111572 |
| 510k Number | K111572 |
| Device Name: | NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SERF 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb SERF 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-06 |
| Decision Date | 2011-08-29 |
| Summary: | summary |