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FDA 510(k)

BPS Wrist Fracture System

K-Number: K242343 · 2024-10-04

ApplicantOrthonovis, Inc.
Decision Date2024-10-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BPS Wrist Fracture System is a medical device manufactured by Orthonovis, Inc.. It received FDA 510(k) clearance on 2024-10-04 under approval number K242343. 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 BPS Wrist Fracture System?

BPS Wrist Fracture System is a medical device that received FDA 510(k) clearance on 2024-10-04. It is manufactured by Orthonovis, Inc.. The 510(k) number is K242343.

When was BPS Wrist Fracture System approved by the FDA?

BPS Wrist Fracture System received FDA 510(k) clearance on 2024-10-04, under approval number K242343.

What company makes BPS Wrist Fracture System?

BPS Wrist Fracture System is manufactured by Orthonovis, Inc..

What is the FDA product code for BPS Wrist Fracture System?

The FDA product code for BPS Wrist Fracture System is HRS.

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Other Devices by Orthonovis, Inc.

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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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