The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Imbibe Needle.
| Device ID | K140414 |
| 510k Number | K140414 |
| Device Name: | IMBIBE NEEDLE |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | ORTHOVITA, INC. 77 Great Valley Parkway Malvern, PA 19355 |
| Contact | John Urtz |
| Correspondent | John Urtz ORTHOVITA, INC. 77 Great Valley Parkway Malvern, PA 19355 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-04-01 |
| Summary: | summary |