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 |