The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker High Vacuum Bone Cement Mixer/inject Syst.
| Device ID | K912190 |
| 510k Number | K912190 |
| Device Name: | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST |
| Classification | Mixer, Cement, For Clinical Use |
| Applicant | STRYKER CORP. P.O. BOX 4085 Kalamazoo, MI 49003 -4085 |
| Contact | Harmon H Woodworth |
| Correspondent | Harmon H Woodworth STRYKER CORP. P.O. BOX 4085 Kalamazoo, MI 49003 -4085 |
| Product Code | JDZ |
| CFR Regulation Number | 888.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-17 |
| Decision Date | 1991-08-29 |