The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Ceramic Femoral Head-28mm Long, Modification.
| Device ID | K925512 |
| 510k Number | K925512 |
| Device Name: | CERAMIC FEMORAL HEAD-28MM LONG, MODIFICATION |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Micki Roy |
| Correspondent | Micki Roy DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-17 |
| Decision Date | 1993-02-12 |