The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Zimmer Mis Light.
| Device ID | K080367 |
| 510k Number | K080367 |
| Device Name: | ZIMMER MIS LIGHT |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Contact | Elsa A Linke |
| Correspondent | Elsa A Linke ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-12 |
| Decision Date | 2008-02-22 |
| Summary: | summary |