The following data is part of a premarket notification filed by Imaging Therapeutics, Inc. with the FDA for Knee Interpositional Mini-repair System (kimrs).
| Device ID | K033242 |
| 510k Number | K033242 |
| Device Name: | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) |
| Classification | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) |
| Applicant | IMAGING THERAPEUTICS, INC. 1720 SOUTH AMPHLETT BLVD. SUITE 240 San Mateo, CA 94402 |
| Contact | Lyndall Erb |
| Correspondent | Lyndall Erb IMAGING THERAPEUTICS, INC. 1720 SOUTH AMPHLETT BLVD. SUITE 240 San Mateo, CA 94402 |
| Product Code | HSH |
| CFR Regulation Number | 888.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-07 |
| Decision Date | 2003-12-31 |
| Summary: | summary |