The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Mini Cannulated Headed And Headless Screw Set.
| Device ID | K183104 |
| 510k Number | K183104 |
| Device Name: | Mini Cannulated Headed And Headless Screw Set |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Sanja Jahr |
| Correspondent | Sanja Jahr Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-08 |
| Decision Date | 2019-06-10 |