The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed X-fix.
| Device ID | K101375 |
| 510k Number | K101375 |
| Device Name: | TRIMED X-FIX |
| Classification | System, External Fixator (with Metallic Invasive Components) |
| Applicant | TRIMED, INC. 28337 MAITLAND LANE Saugus, CA 91350 |
| Contact | Kelli Anderson |
| Correspondent | Kelli Anderson TRIMED, INC. 28337 MAITLAND LANE Saugus, CA 91350 |
| Product Code | NDK |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2010-09-15 |
| Summary: | summary |