The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Fixation Devices And Bone Plate.
| Device ID | K910175 |
| 510k Number | K910175 |
| Device Name: | FIXATION DEVICES AND BONE PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Siddharth Desai |
| Correspondent | Siddharth Desai MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-15 |
| Decision Date | 1991-06-21 |