The following data is part of a premarket notification filed by Zimmer Medizinsysteme Gmbh with the FDA for Cryo 7.
| Device ID | K220020 |
| 510k Number | K220020 |
| Device Name: | Cryo 7 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Zimmer MedizinSysteme GmbH Junkersstrasse 9 Neu-ulm, DE 89231 |
| Contact | Ute Killet |
| Correspondent | Scott Blood Quality And Regulatory Services 151 Gleasondale Road Stow, MA 01775 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815080848 | K220020 | 000 |