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 |