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FDA 510(k)

STAX FINGER SPLINTS

K-Number: K823393 · 1982-12-03

ApplicantOrthopedic Systems, Inc.
Decision Date1982-12-03
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STAX FINGER SPLINTS is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K823393. The device is classified under product code ILH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAX FINGER SPLINTS?

STAX FINGER SPLINTS is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K823393.

When did STAX FINGER SPLINTS receive FDA 510(k) clearance?

STAX FINGER SPLINTS received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823393.

Who is the listed applicant for STAX FINGER SPLINTS?

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

What is the FDA product code for STAX FINGER SPLINTS?

The FDA product code for STAX FINGER SPLINTS is ILH.

Related Clinical Trials

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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Related Devices (Code: ILH)

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.

K832144SPLINT WOODVermont Wood Industries, Inc.K831548SPLINTSFred Sammons, Inc.K823647FINGER EXTENSION SPLINTFred Sammons, Inc.K823644FINGER FLEXION SPLINTFred Sammons, Inc.K823666UNIVERSAL WRIST SPLINT & FOREARM SPLINTWarm & Form, Orthopedic MaterialsK823601WRIST SUPPORTFred Sammons, Inc.

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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