Modification To:Sbi Ringfix

Q: What is the product code of K071394?

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) K071394 · Small Bone Innovations, Inc.

Substantially Equivalent

510(k) numberK071394

Submission

Device name: Modification To:Sbi Ringfix
Applicant: Small Bone Innovations, Inc.
New York, NY, US
Received: May 21, 2007
Decision date: June 29, 2007
Decision: Substantially Equivalent (SESE)
Type: Special 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
K130147	Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)HSB · Special	05/03/2013SE
K112982	Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail )HSB · Traditional	04/02/2012SE
K102180	Rhead Radial Head Extended StemsJDB · Traditional	12/20/2010SE
K092754	Sbi Foot and Ankle Cannulated Screw System, Model 100-0061HWC · Traditional	01/19/2010SE
K093550	Mini Rail External Fixator SystemKTT · Special	01/07/2010SE
K073635	Sbi SR MTP Toe ImplantKWD · Traditional	03/19/2008SE
K071541	Sbi TwistofixHWC · Traditional	09/10/2007SE
K063635	Sbi Forefoot SetHWC · Traditional	08/29/2007SE
K071656	Sbi ArtfixHWC · Traditional	08/27/2007SE
K071540	Sbi Titanium Threaded PinJDW · Traditional	08/08/2007SE

Questions and answers

When was Modification To:Sbi Ringfix cleared by the FDA?

Modification To:Sbi Ringfix (K071394) received a 510(k) decision of Substantially Equivalent on June 29, 2007, 39 days after the submission was received.

What is the product code of K071394?

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.