The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Smf Hip Stem.
| Device ID | K103256 |
| 510k Number | K103256 |
| Device Name: | SMITH & NEPHEW SMF HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Natalie P Williams |
| Correspondent | Natalie P Williams SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-03 |
| Decision Date | 2011-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010657909 | K103256 | 000 |
| 03596010657893 | K103256 | 000 |
| 03596010657886 | K103256 | 000 |
| 03596010657879 | K103256 | 000 |