The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Vertebral Body And Bone Biopsy Kits, Stryker Capture Body And Bone Biospsy Kits.
| Device ID | K032943 |
| 510k Number | K032943 |
| Device Name: | STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS |
| Classification | Instrument, Biopsy |
| Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Dannielle Wheeler |
| Correspondent | Dannielle Wheeler STRYKER CORP. 4100 E. MILHAM AVE. 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 | 2003-09-22 |
| Decision Date | 2003-12-17 |
| Summary: | summary |