TRIGEN META-TAN Trochanteric Antegrade Nail
K-Number: K243364 · 2024-12-09
ApplicantSmith & Nephew, Inc.
Decision Date2024-12-09
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TRIGEN META-TAN Trochanteric Antegrade Nail is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-12-09 under approval number K243364. 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 TRIGEN META-TAN Trochanteric Antegrade Nail?
TRIGEN META-TAN Trochanteric Antegrade Nail is a medical device that received FDA 510(k) clearance on 2024-12-09. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K243364.
When was TRIGEN META-TAN Trochanteric Antegrade Nail approved by the FDA?
TRIGEN META-TAN Trochanteric Antegrade Nail received FDA 510(k) clearance on 2024-12-09, under approval number K243364.
What company makes TRIGEN META-TAN Trochanteric Antegrade Nail?
TRIGEN META-TAN Trochanteric Antegrade Nail is manufactured by Smith & Nephew, Inc..
What is the FDA product code for TRIGEN META-TAN Trochanteric Antegrade Nail?
The FDA product code for TRIGEN META-TAN Trochanteric Antegrade Nail is HSB.
Other Devices by Smith & Nephew, Inc.
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.