The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Minilok Quickanchor Plus.
| Device ID | K030995 |
| 510k Number | K030995 |
| Device Name: | MINILOK QUICKANCHOR PLUS |
| Classification | Screw, Fixation, Bone |
| Applicant | MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Ruth C Forstadt |
| Correspondent | Ruth C Forstadt MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705002412 | K030995 | 000 |
| 10886705002405 | K030995 | 000 |
| 10886705002399 | K030995 | 000 |