The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Mis Hip Stem With Stiktite.
| Device ID | K080625 |
| 510k Number | K080625 |
| Device Name: | SMITH & NEPHEW MIS HIP STEM WITH STIKTITE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha 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 | 2008-03-05 |
| Decision Date | 2008-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010619655 | K080625 | 000 |
| 03596010619648 | K080625 | 000 |
| 03596010619631 | K080625 | 000 |
| 03596010619624 | K080625 | 000 |
| 03596010619617 | K080625 | 000 |
| 03596010619600 | K080625 | 000 |
| 03596010619594 | K080625 | 000 |
| 03596010619587 | K080625 | 000 |
| 03596010619570 | K080625 | 000 |