The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker System 4000 Heavy Duty Battery Powered Equipment.
| Device ID | K972367 |
| 510k Number | K972367 |
| Device Name: | STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Melissa Harriger |
| Correspondent | Melissa Harriger STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-25 |
| Decision Date | 1997-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153092735 | K972367 | 000 |
| 04546540216403 | K972367 | 000 |
| 04546540216427 | K972367 | 000 |
| 04546540216434 | K972367 | 000 |
| 04546540216441 | K972367 | 000 |
| 04546540216458 | K972367 | 000 |
| 04546540216465 | K972367 | 000 |
| 04546540216472 | K972367 | 000 |
| 04546540216489 | K972367 | 000 |
| 04546540216496 | K972367 | 000 |
| 04546540216502 | K972367 | 000 |
| 04546540216519 | K972367 | 000 |
| 04546540216526 | K972367 | 000 |
| 04546540378019 | K972367 | 000 |
| 04546540959683 | K972367 | 000 |
| 04546540216397 | K972367 | 000 |