The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Hydroxylapatite Infinity(r).
| Device ID | K920969 |
| 510k Number | K920969 |
| Device Name: | HYDROXYLAPATITE INFINITY(R) |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Kim Topkins |
| Correspondent | Kim Topkins DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1993-05-05 |