The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Hip Systems With Ha.
| Device ID | K090982 |
| 510k Number | K090982 |
| Device Name: | SMITH & NEPHEW HIP SYSTEMS WITH HA |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Mandy Coe |
| Correspondent | Mandy Coe SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MEH |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2010-04-21 |
| Summary: | summary |