The following data is part of a premarket notification filed by Micro Surgical Instruments Corp. with the FDA for Model 2250-000 Zimmer Style Sagittal Saw Module.
| Device ID | K915139 |
| 510k Number | K915139 |
| Device Name: | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Contact | Moe Khosravi |
| Correspondent | Moe Khosravi MICRO SURGICAL INSTRUMENTS CORP. 24971 AVENUE STANFORD WEST Valencia, CA 91355 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-02-05 |