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FDA 510(k)

ANKLE (FREEMAN-SWANSON)

K-Number: K761020 · 1976-11-23

ApplicantMedishield, Inc.
Decision Date1976-11-23
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANKLE (FREEMAN-SWANSON) is the device name listed in this FDA 510(k) record. The listed applicant is Medishield, Inc.. It received FDA 510(k) clearance on 1976-11-23 under 510(k) number K761020. 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 ANKLE (FREEMAN-SWANSON)?

ANKLE (FREEMAN-SWANSON) is a medical device that received FDA 510(k) clearance on 1976-11-23. The listed applicant is Medishield, Inc.. The 510(k) number is K761020.

When did ANKLE (FREEMAN-SWANSON) receive FDA 510(k) clearance?

ANKLE (FREEMAN-SWANSON) received FDA 510(k) clearance on 1976-11-23, under 510(k) number K761020.

Who is the listed applicant for ANKLE (FREEMAN-SWANSON)?

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

What is the FDA product code for ANKLE (FREEMAN-SWANSON)?

The FDA product code for ANKLE (FREEMAN-SWANSON) is HSN.

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Other records listing Medishield, Inc. 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.

K781103SPECTRASCANK780645HMD-2000 BATTERY-POWERED MINI-DRILL, THEK780646AIR-PWOERED COLDRILLK780202MONOMER EVACUATION SYSTEMK770161MICROFENESTRATED HIP REPLACEMENT COMPON.K761021ANKLE INSTRUMENTS (FREEMAN-SWANSON)

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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, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

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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