Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Craniomaxillofacial Distraction System (CMFD)

K-Number: K170818 · 2017-12-07

ApplicantSynthes USA Products, LLC
Decision Date2017-12-07
Product CodePBJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Craniomaxillofacial Distraction System (CMFD) is a medical device manufactured by Synthes USA Products, LLC. It received FDA 510(k) clearance on 2017-12-07 under approval number K170818. The device is classified under product code PBJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Craniomaxillofacial Distraction System (CMFD)?

Craniomaxillofacial Distraction System (CMFD) is a medical device that received FDA 510(k) clearance on 2017-12-07. It is manufactured by Synthes USA Products, LLC. The 510(k) number is K170818.

When was Craniomaxillofacial Distraction System (CMFD) approved by the FDA?

Craniomaxillofacial Distraction System (CMFD) received FDA 510(k) clearance on 2017-12-07, under approval number K170818.

What company makes Craniomaxillofacial Distraction System (CMFD)?

Craniomaxillofacial Distraction System (CMFD) is manufactured by Synthes USA Products, LLC.

What is the FDA product code for Craniomaxillofacial Distraction System (CMFD)?

The FDA product code for Craniomaxillofacial Distraction System (CMFD) is PBJ.

Related Clinical Trials

NCT07493200 The Effect of Earplugs on Gag Reflex and Patient Comfort in Root Canal Treatment ACTIVE_NOT_RECRUITING NCT06782360 Cognitive Augmentation Via Multimodal Sensing and Auricular Neurostimulation COMPLETED NCT07079774 TrueLok Elevate PMCF Study RECRUITING NCT07497451 Enhancing Pain Management Among Patients Diagnosed With Stage III and Stage IV of Breast Cancer: The Power of Immersive and Non-Immersive Virtual Reality-Driven Interactive Guided Imagery NOT_YET_RECRUITING

Other Devices by Synthes USA Products, LLC

K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System K162594Craniomaxillofacial Distraction System (CMFD) K170654USS System K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw K180541DePuy Synthes 2.0 mm Quick Insertion Screws

Related Devices (Code: PBJ)

K163315Internal Distraction - SterileKLS Martin L.P. K230211CranioXpandKLS-Martin L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑