The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Imbibe Bone Marrow Aspiration Needle.
| Device ID | K050795 |
| 510k Number | K050795 |
| Device Name: | IMBIBE BONE MARROW ASPIRATION NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | ORTHOVITA, INC. 1835 MARKET ST. 28TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan ORTHOVITA, INC. 1835 MARKET ST. 28TH FLOOR Philadelphia, PA 19103 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-29 |
| Decision Date | 2005-06-03 |
| Summary: | summary |