The following data is part of a premarket notification filed by Medartis, Inc. with the FDA for Modus Modular Distraction Osteogenesis System.
| Device ID | K051946 |
| 510k Number | K051946 |
| Device Name: | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | MEDARTIS, INC. 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson MEDARTIS, INC. 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-08-22 |
| Summary: | summary |