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FDA 510(k)

SCHLEIN TRI-SURFACE ANKLE

K-Number: K800530 · 1980-04-02

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1980-04-02
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCHLEIN TRI-SURFACE ANKLE is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800530. 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 SCHLEIN TRI-SURFACE ANKLE?

SCHLEIN TRI-SURFACE ANKLE is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K800530.

When did SCHLEIN TRI-SURFACE ANKLE receive FDA 510(k) clearance?

SCHLEIN TRI-SURFACE ANKLE received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800530.

Who is the listed applicant for SCHLEIN TRI-SURFACE ANKLE?

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

What is the FDA product code for SCHLEIN TRI-SURFACE ANKLE?

The FDA product code for SCHLEIN TRI-SURFACE ANKLE is HSN.

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Other records listing Orthopedic Equipment Co., Inc. as applicant

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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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