The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Mitek Micro Quickanchor.
| Device ID | K032078 |
| 510k Number | K032078 |
| Device Name: | MITEK MICRO QUICKANCHOR |
| Classification | Anchor, Suture, Bone Fixation, Metallic |
| Applicant | MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood, MA 02062 |
| Contact | Sergio J Gadaleta |
| Correspondent | Sergio J Gadaleta MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE Norwood, MA 02062 |
| Product Code | NOV |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2003-08-25 |
| Summary: | summary |