The following data is part of a premarket notification filed by Ot Medical with the FDA for Instafix Shape Memory Fixation System.
| Device ID | K141550 |
| 510k Number | K141550 |
| Device Name: | INSTAFIX SHAPE MEMORY FIXATION SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | OT MEDICAL 1000 CONTINENTAL DRIVE, SUITE 240 King Of Prussia, PA 19406 |
| Contact | William Rhoda |
| Correspondent | William Rhoda OT MEDICAL 1000 CONTINENTAL DRIVE, SUITE 240 King Of Prussia, PA 19406 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-11 |
| Decision Date | 2014-07-11 |
| Summary: | summary |