FDA 510(k)

Affixus Hip Fracture Nail

K-Number: K183162 · 2018-12-14

Decision Date2018-12-14

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Affixus Hip Fracture Nail is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2018-12-14 under approval number K183162. 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 Hip Fracture Nail?

Affixus Hip Fracture Nail is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Biomet, Inc.. The 510(k) number is K183162.

When was Affixus Hip Fracture Nail approved by the FDA?

Affixus Hip Fracture Nail received FDA 510(k) clearance on 2018-12-14, under approval number K183162.

What company makes Affixus Hip Fracture Nail?

Affixus Hip Fracture Nail is manufactured by Biomet, Inc..

What is the FDA product code for Affixus Hip Fracture Nail?

The FDA product code for Affixus Hip Fracture Nail is HSB.

Other Devices by Biomet, Inc.

K161592Persona Partial Knee System K162424Ulna Plating System K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System

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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.