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FDA 510(k)

A.C. SPLINT

K-Number: K823810 · 1983-01-14

ApplicantDanek Medical, Inc.
Decision Date1983-01-14
Product CodeILI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

A.C. SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823810. The device is classified under product code ILI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.C. SPLINT?

A.C. SPLINT is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Danek Medical, Inc.. The 510(k) number is K823810.

When did A.C. SPLINT receive FDA 510(k) clearance?

A.C. SPLINT received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823810.

Who is the listed applicant for A.C. SPLINT?

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

What is the FDA product code for A.C. SPLINT?

The FDA product code for A.C. SPLINT is ILI.

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Other records listing Danek Medical, Inc. as applicant

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Related Devices (Code: ILI)

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.

K912661MATRX, PYRAMID TRIANGLE BANDAGEMatrix Medica, Inc.K831549ARM SLINGSFred Sammons, Inc.K831706SATO FAMILY FIRST AID KITFood and Drug Service, Inc.K823808VARIOUS ARM SLINGDanek Medical, Inc.K823664UNIVERSAL SLING, SLING & SWATHEWarm & Form, Orthopedic MaterialsK823162UNIVERSAL SLING, SLING & SWATHEWarm & Form, Orthopedic Materials

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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