The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Biocryl Interference Screws.
| Device ID | K013572 |
| 510k Number | K013572 |
| Device Name: | MITEK BIOCRYL INTERFERENCE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Christine Kuntz-nassif |
| Correspondent | Christine Kuntz-nassif MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-29 |
| Decision Date | 2002-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705010660 | K013572 | 000 |
| 10886705010653 | K013572 | 000 |
| 10886705010646 | K013572 | 000 |
| 10886705010639 | K013572 | 000 |
| 10886705010622 | K013572 | 000 |
| 10886705010615 | K013572 | 000 |
| 10886705010608 | K013572 | 000 |
| 10886705010592 | K013572 | 000 |
| 10886705010585 | K013572 | 000 |