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FDA 510(k)

PROSTEP TBC Implant System

K-Number: K183620 · 2019-06-06

ApplicantWrightmedicaltechnologyinc
Decision Date2019-06-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROSTEP TBC Implant System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-06-06 under approval number K183620. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTEP TBC Implant System?

PROSTEP TBC Implant System is a medical device that received FDA 510(k) clearance on 2019-06-06. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K183620.

When was PROSTEP TBC Implant System approved by the FDA?

PROSTEP TBC Implant System received FDA 510(k) clearance on 2019-06-06, under approval number K183620.

What company makes PROSTEP TBC Implant System?

PROSTEP TBC Implant System is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for PROSTEP TBC Implant System?

The FDA product code for PROSTEP TBC Implant System is HRS.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Wrightmedicaltechnologyinc

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Related Devices (Code: HRS)

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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.

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