The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Universal Mesh - Sterile.
| Device ID | K182425 |
| 510k Number | K182425 |
| Device Name: | Universal Mesh - Sterile |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Contact | Gregory Gohl |
| Correspondent | Gregory Gohl Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-06 |
| Decision Date | 2018-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327382563 | K182425 | 000 |
| 07613327382419 | K182425 | 000 |
| 07613327382426 | K182425 | 000 |
| 07613327382433 | K182425 | 000 |
| 07613327382440 | K182425 | 000 |
| 07613327382457 | K182425 | 000 |
| 07613327382464 | K182425 | 000 |
| 07613327382471 | K182425 | 000 |
| 07613327382488 | K182425 | 000 |
| 07613327382495 | K182425 | 000 |
| 07613327382501 | K182425 | 000 |
| 07613327382518 | K182425 | 000 |
| 07613327382525 | K182425 | 000 |
| 07613327382532 | K182425 | 000 |
| 07613327382549 | K182425 | 000 |
| 07613327382556 | K182425 | 000 |
| 07613327382402 | K182425 | 000 |