The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Orthopower 90 & Orthopower 90 System Ii.
| Device ID | K863447 |
| 510k Number | K863447 |
| Device Name: | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Contact | Harmon H Woodworth |
| Correspondent | Harmon H Woodworth STRYKER CORP. 420 ALCOTT ST. Kalamazoo, MI 49001 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-08 |
| Decision Date | 1986-09-29 |