Isoelasticu

FDA 510(k) K081025 · Remi Sciences, Inc.

Substantially Equivalent

510(k) numberK081025

Submission

Device name
Isoelasticu
Applicant
Remi Sciences, Inc.
Lititz, PA, US
Received
April 10, 2008
Decision date
November 21, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXE – Prosthesis, Wrist, Hemi-, Ulnar
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3810
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KXE

510(k)DeviceApplicantDecision
K190599Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional Aptis Medical, LLC05/03/2019SE
K142569Aptis Medical Distal Radio Ulnar Joint ImplantKXE · Traditional Aptis Medical, LLC04/03/2015SE
K112481First Choice Druj System, Partial Head ImplantKXE · Traditional Ascension Orthopedic04/09/2012SE
K082839Distal Radio-Ulnar Joint ImplantKXE · Special Aptis Medical, LLC10/24/2008SE
K061146Sbi Ulnar Head ImplantKXE · Special Small Bone Innovations, Inc.07/19/2006SE
K053119Distal Radio-Ulnar Joint ImplantKXE · Special Aptis Medical, LLC12/07/2005SE
K052137Ascension MuhKXE · Traditional Ascension Orthopedics, Inc.11/03/2005SE
K040497Distal Radio-Ulnar Joint ImplantKXE · Traditional Aptis Medical, LLC01/26/2005SE
K042902Herbert Ulnar Head Prosthesis SystemKXE · Traditional Stuckenbrock Medizintechnik GmbH12/27/2004SE
K033930Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional Kapp Surgical Instrument, Inc.07/28/2004SE

Questions and answers

When was Isoelasticu cleared by the FDA?

Isoelasticu (K081025) received a 510(k) decision of Substantially Equivalent on November 21, 2008, 225 days after the submission was received.

What is the product code of K081025?

The FDA product code is KXE – Prosthesis, Wrist, Hemi-, Ulnar, a Class II (moderate risk) device regulated under 21 CFR 888.3810.