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FDA 510(k)

DYNAMIC EXTENSOR SPLINT

K-Number: K800143 · 1980-02-19

ApplicantBiomet, Inc.
Decision Date1980-02-19
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNAMIC EXTENSOR SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1980-02-19 under 510(k) number K800143. 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 DYNAMIC EXTENSOR SPLINT?

DYNAMIC EXTENSOR SPLINT is a medical device that received FDA 510(k) clearance on 1980-02-19. The listed applicant is Biomet, Inc.. The 510(k) number is K800143.

When did DYNAMIC EXTENSOR SPLINT receive FDA 510(k) clearance?

DYNAMIC EXTENSOR SPLINT received FDA 510(k) clearance on 1980-02-19, under 510(k) number K800143.

Who is the listed applicant for DYNAMIC EXTENSOR SPLINT?

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

What is the FDA product code for DYNAMIC EXTENSOR SPLINT?

The FDA product code for DYNAMIC EXTENSOR SPLINT is ILH.

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Other records listing Biomet, Inc. as applicant

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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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