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FDA 510(k)

Prophecy Surgical Planning System

K-Number: K241999 · 2024-11-01

ApplicantWright Medical Technology, Inc. (Stryker)
Decision Date2024-11-01
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prophecy Surgical Planning System is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology, Inc. (Stryker). It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K241999. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prophecy Surgical Planning System?

Prophecy Surgical Planning System is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Wright Medical Technology, Inc. (Stryker). The 510(k) number is K241999.

When did Prophecy Surgical Planning System receive FDA 510(k) clearance?

Prophecy Surgical Planning System received FDA 510(k) clearance on 2024-11-01, under 510(k) number K241999.

Who is the listed applicant for Prophecy Surgical Planning System?

The FDA 510(k) record lists Wright Medical Technology, Inc. (Stryker) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prophecy Surgical Planning System?

The FDA product code for Prophecy Surgical Planning System is HSN.

Other records listing Wright Medical Technology, Inc. (Stryker) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemK251643Synchfix EVTK252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)K250037Incompass Total Ankle System

Related Devices (Code: HSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK242868Kinos Total Ankle SystemRestor3D

Official Source

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

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