The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Mitek Rapidloc-pds Meniscal Repair System.
| Device ID | K023388 |
| 510k Number | K023388 |
| Device Name: | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Petra C Smit |
| Correspondent | Petra C Smit MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-09 |
| Decision Date | 2002-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705010202 | K023388 | 000 |
| 10886705010196 | K023388 | 000 |
| 10886705010189 | K023388 | 000 |