The following data is part of a premarket notification filed by Russell B. Walther with the FDA for Sprytie, Models St001, St002 And St003.
| Device ID | K092530 |
| 510k Number | K092530 |
| Device Name: | SPRYTIE, MODELS ST001, ST002 AND ST003 |
| Classification | Wire, Fixation, Intraosseous |
| Applicant | RUSSELL B. WALTHER 6026 MARTEL AVENUE Dallas, TX 75206 |
| Contact | Russell B Walther |
| Correspondent | Russell B Walther RUSSELL B. WALTHER 6026 MARTEL AVENUE Dallas, TX 75206 |
| Product Code | DZK |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-18 |
| Decision Date | 2010-04-02 |
| Summary: | summary |