The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Dyonics Plan Hip Impingement Planning System.
| Device ID | K132636 |
| 510k Number | K132636 |
| Device Name: | DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Kathleen Solomon |
| Correspondent | Kathleen Solomon SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-22 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556604199 | K132636 | 000 |
| 00885556604182 | K132636 | 000 |
| 00885556604175 | K132636 | 000 |
| 00885556604168 | K132636 | 000 |
| 00885556604151 | K132636 | 000 |