The following data is part of a premarket notification filed by Crosstrees Medical, Inc. with the FDA for Crosstrees Pva Pod.
Device ID | K133372 |
510k Number | K133372 |
Device Name: | CROSSTREES PVA POD |
Classification | Cement, Bone, Vertebroplasty |
Applicant | CROSSTREES MEDICAL, INC. 135 MARKET ST., 29TH FLOOR Philadelphia, PA 19119 |
Contact | Janice Hogan |
Correspondent | Janice Hogan CROSSTREES MEDICAL, INC. 135 MARKET ST., 29TH FLOOR Philadelphia, PA 19119 |
Product Code | NDN |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-01 |
Decision Date | 2013-12-06 |
Summary: | summary |