The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Btb Absorbable (pla) Cross Pin.
| Device ID | K974341 |
| 510k Number | K974341 |
| Device Name: | MITEK BTB ABSORBABLE (PLA) CROSS PIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Robert Zoletti |
| Correspondent | Robert Zoletti MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-18 |
| Decision Date | 1998-04-16 |
| Summary: | summary |