The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Stryker Kwic Needle.
| Device ID | K140868 |
| 510k Number | K140868 |
| Device Name: | STRYKER KWIC NEEDLE |
| Classification | Neurological Stereotaxic 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 | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808232001365 | K140868 | 000 |