Odi Talon Intramedullary Hip Nail

Q: What is the product code of K014189?

The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.

FDA 510(k) K014189 · Orthopedic Designs, Inc.

Substantially Equivalent

510(k) numberK014189

Submission

Device name: Odi Talon Intramedullary Hip Nail
Applicant: Orthopedic Designs, Inc.
St. Petersburg, FL, US
Received: December 21, 2001
Decision date: March 21, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JDS – Nail, Fixation, Bone
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3030
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code JDS

510(k)	Device	Applicant	Decision
K243608	TRIGEN Stable Lock Nut & WasherJDS · Traditional	Smith & Nephew, Inc.	06/12/2025SE
K240061	TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS · Traditional	Smith & Nephew, Inc.	09/20/2024SE
K241804	TRIGEN INTERTAN 10S Nail SystemJDS · Traditional	Smith & Nephew, Inc.	08/22/2024SE
K233150	NET BRAND Osteosynthesis Nailing SystemJDS · Traditional	Narang Medical , Ltd.	02/20/2024SE
K230761	TRIGEN META-NAIL Nail SystemJDS · Traditional	Smith & Nephew, Inc.	06/14/2023SE
K201336	DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional	Synthes (USA) Products, LLC	09/03/2020SE
K192003	Auxein Nailing SystemJDS · Traditional	Auxein Medical Private Limited	06/10/2020SE
K193533	WIN Flexible Nail SystemJDS · Traditional	Biomet, Inc.	02/20/2020SE
K141737	Conventus PHS SystemJDS · Traditional	Conventus Orthopaedics, Inc.	04/08/2015SE
K123948	China Nails and AccessoriesJDS · Traditional	Smith & Nephew, Inc.	03/14/2013SE

More from Smith & Nephew, Inc.

510(k)	Device	Decision
K030619	Odi 7.0MM Cannulated Screw SystemHTN · Traditional	04/01/2003SE
K984331	Odi Ultimate Compression Hip ScrewHWC · Traditional	01/20/1999SE
K972722	Ultimate Compression Screw SystemHWC · Traditional	01/23/1998SN

Questions and answers

When was Odi Talon Intramedullary Hip Nail cleared by the FDA?

Odi Talon Intramedullary Hip Nail (K014189) received a 510(k) decision of Substantially Equivalent on March 21, 2002, 90 days after the submission was received.

What is the product code of K014189?

The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.