The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Ivas 8g Bone Biopsy Kit, Ivas 11g Bone Biopsy Kit, Ivas 10g Bone Biopsy Kit.
| Device ID | K172558 |
| 510k Number | K172558 |
| Device Name: | IVAS 8g Bone Biopsy Kit, IVAS 11g Bone Biopsy Kit, IVAS 10g Bone Biopsy Kit |
| Classification | Instrument, Biopsy |
| Applicant | Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 |
| Contact | Kristi Ashton |
| Correspondent | Kristi Ashton Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-24 |
| Decision Date | 2017-10-05 |
| Summary: | summary |