The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Imbibe Needle.
| Device ID | K153306 |
| 510k Number | K153306 |
| Device Name: | Imbibe Needle |
| Classification | Instrument, Biopsy |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Lynn Lundy |
| Correspondent | Lynn Lundy ORTHOVITA, INC. 77 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-16 |
| Decision Date | 2015-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327123623 | K153306 | 000 |
| 07613327123616 | K153306 | 000 |
| 07613327123609 | K153306 | 000 |
| 07613327123593 | K153306 | 000 |
| 07613327123586 | K153306 | 000 |
| 07613327123579 | K153306 | 000 |
| 07613327123562 | K153306 | 000 |
| 07613327123555 | K153306 | 000 |