The following data is part of a premarket notification filed by Zimmer Knee Creations, Inc. with the FDA for Mixing Syringe System.
| Device ID | K133021 |
| 510k Number | K133021 |
| Device Name: | MIXING SYRINGE SYSTEM |
| Classification | Syringe, Piston |
| Applicant | ZIMMER KNEE CREATIONS, INC. 841 Springdale Drive Exton, PA 19341 |
| Contact | Shaun Hanson |
| Correspondent | Shaun Hanson ZIMMER KNEE CREATIONS, INC. 841 Springdale Drive Exton, PA 19341 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2014-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024406452 | K133021 | 000 |