Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

United Orthopedic Knee Patient Specific Instrumentation

K-Number: K230850 · 2023-12-20

ApplicantEnhatch, Inc.
Decision Date2023-12-20
Product CodeOOG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

United Orthopedic Knee Patient Specific Instrumentation is a medical device manufactured by Enhatch, Inc.. It received FDA 510(k) clearance on 2023-12-20 under approval number K230850. The device is classified under product code OOG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the United Orthopedic Knee Patient Specific Instrumentation?

United Orthopedic Knee Patient Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Enhatch, Inc.. The 510(k) number is K230850.

When was United Orthopedic Knee Patient Specific Instrumentation approved by the FDA?

United Orthopedic Knee Patient Specific Instrumentation received FDA 510(k) clearance on 2023-12-20, under approval number K230850.

What company makes United Orthopedic Knee Patient Specific Instrumentation?

United Orthopedic Knee Patient Specific Instrumentation is manufactured by Enhatch, Inc..

What is the FDA product code for United Orthopedic Knee Patient Specific Instrumentation?

The FDA product code for United Orthopedic Knee Patient Specific Instrumentation is OOG.

Related Clinical Trials

NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT04806347 Alpha/Beta T-cell Depleted Blood-forming Stem Cell Transplant From Related or Unrelated Donors for Blood Diseases in Children and Young Adults NOT_YET_RECRUITING NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 41543941 Opportunities and Challenges in Precision Neurotherapeutics. Annual review of biomedical engineering (2026)

Related Devices (Code: OOG)

K203421Triathlon AS-1Conformis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑