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FDA 510(k)

LIGAMENTOPLASTIC STAPLE OF L'UNION

K-Number: K911020 · 1991-05-29

ApplicantSport Service, Inc.
Decision Date1991-05-29
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIGAMENTOPLASTIC STAPLE OF L'UNION is the device name listed in this FDA 510(k) record. The listed applicant is Sport Service, Inc.. It received FDA 510(k) clearance on 1991-05-29 under 510(k) number K911020. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGAMENTOPLASTIC STAPLE OF L'UNION?

LIGAMENTOPLASTIC STAPLE OF L'UNION is a medical device that received FDA 510(k) clearance on 1991-05-29. The listed applicant is Sport Service, Inc.. The 510(k) number is K911020.

When did LIGAMENTOPLASTIC STAPLE OF L'UNION receive FDA 510(k) clearance?

LIGAMENTOPLASTIC STAPLE OF L'UNION received FDA 510(k) clearance on 1991-05-29, under 510(k) number K911020.

Who is the listed applicant for LIGAMENTOPLASTIC STAPLE OF L'UNION?

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

What is the FDA product code for LIGAMENTOPLASTIC STAPLE OF L'UNION?

The FDA product code for LIGAMENTOPLASTIC STAPLE OF L'UNION is JDR.

Related Clinical Trials

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.

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Other records listing Sport Service, 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.

K911021PLATE BLADE WITH CURSOR OF L'UNIONK911031THE TRAMOND PINK911026STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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