Sign Hip Construct (SHC), Model: 701

Q: What is the product code of K083582?

The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.

FDA 510(k) K083582 · Surgical Implant Generation Network (Sign)

Substantially Equivalent

510(k) numberK083582

Submission

Device name: Sign Hip Construct (SHC), Model: 701
Applicant: Surgical Implant Generation Network (Sign)
Richland, WA, US
Received: December 4, 2008
Decision date: August 26, 2009
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3030
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code KTT

510(k)	Device	Applicant	Decision
K254087	MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional	Synthes (USA) Products, LLC	06/11/2026SE
K260900	DYNEX® External Fixation SystemsKTT · Special	Vilex, LLC	04/17/2026SE
K260112	QuikFix External Fixator: Knee-Spanning PackKTT · Traditional	Stabiliz Orthopaedics, Inc.	03/23/2026SE
K253291	Excelsior SystemKTT · Traditional	Blue Ocean Global	01/20/2026SE
K253613	Monkey Rings External Ring Fixation SystemKTT · Special	Paragon 28, Inc.	12/19/2025SE
K253202	Hoffmann LRF SystemKTT · Traditional	Stryker GmbH	12/19/2025SE
K252555	Medusa Orthopedics Boa External Fixation SystemKTT · Traditional	Medusa Orthopedics, LLC	11/25/2025SE
K252625	The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional	Response Ortho Solutions, LLC	11/20/2025SE
K252106	External Fixation Mini Rail SystemKTT · Traditional	Paragon 28, Inc.	09/30/2025SE
K251862	External Fixation Bone DistractorKTT · Traditional	Paragon 28, Inc.	08/11/2025SE

More from Paragon 28, Inc.

510(k)	Device	Decision
K043200	Sign Fin NailHSB · Traditional	02/03/2005SE
K022632	Sign Im NailHSB · Traditional	09/23/2002SE
K013132	Sign Im NailHSB · Traditional	12/20/2001SE

Questions and answers

When was Sign Hip Construct (SHC), Model: 701 cleared by the FDA?

Sign Hip Construct (SHC), Model: 701 (K083582) received a 510(k) decision of Substantially Equivalent on August 26, 2009, 265 days after the submission was received.

What is the product code of K083582?

The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.