The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Universal Cmf System.
| Device ID | K221855 |
| 510k Number | K221855 |
| Device Name: | Universal CMF System |
| Classification | Plate, Bone |
| Applicant | Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Contact | Amelia Kesti |
| Correspondent | Amelia Kesti Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327613438 | K221855 | 000 |
| 07613327628937 | K221855 | 000 |
| 07613327628920 | K221855 | 000 |
| 07613327628913 | K221855 | 000 |
| 07613327628906 | K221855 | 000 |
| 07613327628890 | K221855 | 000 |
| 07613327630671 | K221855 | 000 |
| 07613327630664 | K221855 | 000 |
| 07613327644074 | K221855 | 000 |
| 07613327651089 | K221855 | 000 |
| 07613327651072 | K221855 | 000 |
| 07613327651065 | K221855 | 000 |
| 07613327628944 | K221855 | 000 |
| 07613327628951 | K221855 | 000 |
| 07613327628968 | K221855 | 000 |
| 07613327613421 | K221855 | 000 |
| 07613327613414 | K221855 | 000 |
| 07613327613407 | K221855 | 000 |
| 07613327620993 | K221855 | 000 |
| 07613327623932 | K221855 | 000 |
| 07613327623925 | K221855 | 000 |
| 07613327627312 | K221855 | 000 |
| 07613327627305 | K221855 | 000 |
| 07613327627299 | K221855 | 000 |
| 07613327627282 | K221855 | 000 |
| 07613327627275 | K221855 | 000 |
| 07613327651058 | K221855 | 000 |