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FDA 510(k)

Affixus(R) Natural Nail(R) System Humeral Nail

K-Number: K200814 · 2020-04-28

ApplicantZimmer GmbH
Decision Date2020-04-28
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Affixus(R) Natural Nail(R) System Humeral Nail is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2020-04-28 under approval number K200814. 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 Affixus(R) Natural Nail(R) System Humeral Nail?

Affixus(R) Natural Nail(R) System Humeral Nail is a medical device that received FDA 510(k) clearance on 2020-04-28. It is manufactured by Zimmer GmbH. The 510(k) number is K200814.

When was Affixus(R) Natural Nail(R) System Humeral Nail approved by the FDA?

Affixus(R) Natural Nail(R) System Humeral Nail received FDA 510(k) clearance on 2020-04-28, under approval number K200814.

What company makes Affixus(R) Natural Nail(R) System Humeral Nail?

Affixus(R) Natural Nail(R) System Humeral Nail is manufactured by Zimmer GmbH.

What is the FDA product code for Affixus(R) Natural Nail(R) System Humeral Nail?

The FDA product code for Affixus(R) Natural Nail(R) System Humeral Nail 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 NCT07562971 Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES) NOT_YET_RECRUITING NCT05773352 Perform® Humeral System - Fracture Study (PFX) ACTIVE_NOT_RECRUITING NCT06155695 Auditory Control Enhancement (ACE) in Schizophrenia TERMINATED

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)

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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.

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