Synthes (USA) Condylar Head Add-On System

FDA 510(k) K063181 · Synthes (Usa)

Substantially Equivalent

510(k) numberK063181

Submission

Device name
Synthes (USA) Condylar Head Add-On System
Applicant
Synthes (Usa)
West Chester, PA, US
Received
October 19, 2006
Decision date
January 5, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEI – Prosthesis, Condyle, Mandibular, Temporary
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4770
Specialty
Dental
Implant
Yes

Other 510(k)s with product code NEI

510(k)DeviceApplicantDecision
K133285Stryker Temporary Condylar ProsthesisNEI · Traditional Stryker04/09/2014SE
K081747Modification to Synthes (USA) Condylar Head Add-On SystemNEI · Traditional Synthes (Usa)09/05/2008SE
K031701Osteomed Temporary Condylar Attachment SystemNEI · Traditional Osteomed LP07/08/2004SE
K002790Add-On CondyleNEI · Traditional Walter Lorenz Surgical, Inc.08/06/2001SE
K990667Kls-Martin Temporary Condylar ImplantNEI · Traditional KLS-Martin L.P.07/27/2001SE
K990637Synthes Locking Reconstruction Plate (LRP) with Condylar HeadNEI · Traditional Synthes (Usa)10/22/1999SE

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Questions and answers

When was Synthes (USA) Condylar Head Add-On System cleared by the FDA?

Synthes (USA) Condylar Head Add-On System (K063181) received a 510(k) decision of Substantially Equivalent on January 5, 2007, 78 days after the submission was received.

What is the product code of K063181?

The FDA product code is NEI – Prosthesis, Condyle, Mandibular, Temporary, a Class II (moderate risk) device regulated under 21 CFR 872.4770.