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)

Zimmer Natural Nail System Cephalomedullary Nails

K-Number: K192312 · 2019-10-11

ApplicantZimmer GmbH
Decision Date2019-10-11
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Natural Nail System Cephalomedullary Nails is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2019-10-11 under approval number K192312. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Natural Nail System Cephalomedullary Nails?

Zimmer Natural Nail System Cephalomedullary Nails is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Zimmer GmbH. The 510(k) number is K192312.

When was Zimmer Natural Nail System Cephalomedullary Nails approved by the FDA?

Zimmer Natural Nail System Cephalomedullary Nails received FDA 510(k) clearance on 2019-10-11, under approval number K192312.

What company makes Zimmer Natural Nail System Cephalomedullary Nails?

Zimmer Natural Nail System Cephalomedullary Nails is manufactured by Zimmer GmbH.

What is the FDA product code for Zimmer Natural Nail System Cephalomedullary Nails?

The FDA product code for Zimmer Natural Nail System Cephalomedullary Nails is HSB.

Related Clinical Trials

NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT07560878 Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression RECRUITING NCT07573059 Evaluation of the Safety of Loargys Arginine Test System in Loargys-treated Patients RECRUITING NCT06089291 Persona IQ Cohort Study ENROLLING_BY_INVITATION NCT07562971 Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES) NOT_YET_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING

Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Zimmer GmbH

K161620Anatomical Shoulder Domelock Dome centric K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System K171858Sidus Stem-Free Shoulder K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System K170072Fitmore® Hip Stem

View all 19 devices →

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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.

↑