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 |