The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Orthofix Modulsystem.
| Device ID | K955848 |
| 510k Number | K955848 |
| Device Name: | ORTHOFIX MODULSYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | ORTHOFIX, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Robert L Sheridan |
| Correspondent | Robert L Sheridan ORTHOFIX, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-27 |
| Decision Date | 1996-03-20 |
| Summary: | summary |