The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Knifelight.
| Device ID | K100884 |
| 510k Number | K100884 |
| Device Name: | STRYKER KNIFELIGHT |
| Classification | Lamp, Surgical |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Avital Merl-margulies |
| Correspondent | Avital Merl-margulies HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-30 |
| Decision Date | 2010-06-25 |
| Summary: | summary |