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 | K123012 |
| 510k Number | K123012 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2012-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556168516 | K123012 | 000 |
| 00885556159149 | K123012 | 000 |
| 00885556159194 | K123012 | 000 |
| 00885556159248 | K123012 | 000 |
| 00885556159293 | K123012 | 000 |
| 00885556159347 | K123012 | 000 |
| 00885556159392 | K123012 | 000 |
| 00885556159446 | K123012 | 000 |
| 00885556159491 | K123012 | 000 |
| 00885556159545 | K123012 | 000 |
| 00885556159590 | K123012 | 000 |
| 00885556168165 | K123012 | 000 |
| 00885556168219 | K123012 | 000 |
| 00885556168264 | K123012 | 000 |
| 00885556168318 | K123012 | 000 |
| 00885556168417 | K123012 | 000 |
| 00885556168462 | K123012 | 000 |
| 00885556159095 | K123012 | 000 |