The following data is part of a premarket notification filed by Aston Medical with the FDA for Tregor Dual Mobility Acetabular System.
| Device ID | K111981 |
| 510k Number | K111981 |
| Device Name: | TREGOR DUAL MOBILITY ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | ASTON MEDICAL 577 North Hope Ave Santa Barbara, CA 93110 |
| Contact | Catherine Gloster |
| Correspondent | Catherine Gloster ASTON MEDICAL 577 North Hope Ave Santa Barbara, CA 93110 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-12 |
| Decision Date | 2012-10-12 |
| Summary: | summary |