Devices · Enhatch, Inc.

United Orthopedic Knee Patient Specific Instrumentation

Enhatch, Inc. is listed for United Orthopedic Knee Patient Specific Instrumentation (K230850). The FDA list gives December 20, 2023 as the date of the final decision. The lead panel is Orthopedic, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OOG as “Knee Arthroplasty Implantation System”: Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230850

Official FDA database record

Date of final decision

December 20, 2023

Company on the FDA list

Enhatch, Inc.

Lead panel

Orthopedic

Primary product code

OOG

openFDA device name for the code

Knee Arthroplasty Implantation System

Device class

2

Regulation number

888.3560

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary