The following data is part of a premarket notification filed by Crosstrees Medical, Inc. with the FDA for Crosstrees Pva Pod.
Device ID | K130089 |
510k Number | K130089 |
Device Name: | CROSSTREES PVA POD |
Classification | Cement, Bone, Vertebroplasty |
Applicant | CROSSTREES MEDICAL, INC. 1835 MARKET ST., 28TH FLOOR Philadelphia, PA 19103 |
Contact | Janice M Hogan |
Correspondent | Janice M Hogan CROSSTREES MEDICAL, INC. 1835 MARKET ST., 28TH FLOOR Philadelphia, PA 19103 |
Product Code | NDN |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-14 |
Decision Date | 2013-08-09 |
Summary: | summary |