BRM Digitalis Spacer

FDA 510(k) K220142 · Brm Extremities Srl

Substantially Equivalent

510(k) numberK220142

Submission

Device name
BRM Digitalis Spacer
Applicant
Brm Extremities Srl
Civate, IT
Received
January 18, 2022
Decision date
April 4, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KYJ – Prosthesis, Finger, Constrained, Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3230
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KYJ

510(k)DeviceApplicantDecision
K233670Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special Ascension Orthopedics, Inc.12/14/2023SE
K211385KeriFlex® MCP and PIP Finger Joint ProsthesesKYJ · Traditional Keri Medical SA07/27/2022SE
K140453Osteotec Silicone Finger ImplantKYJ · Traditional Osteotec, Ltd.04/17/2015SE
K083107Modification to Depuy Neuflex Pip FingerKYJ · Traditional DePuy Orthopaedics, Inc.02/09/2009SE
K082231Ascension Silicone PipKYJ · Traditional Ascension Orthopedics, Inc.01/12/2009SE
K022892Ascension Sillicone MCPKYJ · Traditional Ascension Orthopedics, Inc.11/25/2002SE
K013629Finger Joint ProsthesisKYJ · Traditional Avanta Orthopaedics, Inc.01/25/2002SE
K001922Depuy Neuflex Pip FingerKYJ · Traditional Depuy, Inc.08/29/2000SE
K970544Depuy Dupont Orthopaedics Finger Joint ProsthesisKYJ · Traditional Depuy, Inc.09/12/1997SE
K931588Sutter Proximal Interphalangeal JointKYJ · Traditional Sutter Corp.03/10/1994SE

More from Sutter Corp.

510(k)DeviceDecision
K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantHWC · Traditional 12/16/2022SE
K203773BRM TOOL ScrewsHWC · Traditional 01/14/2022SE
K191966NewPrim SystemKWH · Traditional 02/13/2020SE

Questions and answers

When was BRM Digitalis Spacer cleared by the FDA?

BRM Digitalis Spacer (K220142) received a 510(k) decision of Substantially Equivalent on April 4, 2023, 441 days after the submission was received.

What is the product code of K220142?

The FDA product code is KYJ – Prosthesis, Finger, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3230.