The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Asnis Iii Cannulated Screw System, Asnis Pro Cannulated Screw System.
| Device ID | K220319 |
| 510k Number | K220319 |
| Device Name: | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker GmbH 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Danielle Jannuzzi Madureira |
| Correspondent | Danielle Jannuzzi Madureira Stryker GmbH Dr. Homer Stryker Strasse, 1 CH-2545 Selzach, CH |
| Product Code | HWC |
| Subsequent Product Code | HTN |
| Subsequent Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-03 |
| Decision Date | 2022-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327522143 | K220319 | 000 |
| 07613327522112 | K220319 | 000 |
| 07613327522167 | K220319 | 000 |
| 07613327522150 | K220319 | 000 |