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FDA 510(k)

STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION

K-Number: K911026 · 1991-05-29

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

Device Summary

STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE 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 K911026. 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 STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION?

STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE 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 K911026.

When did STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION receive FDA 510(k) clearance?

STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION received FDA 510(k) clearance on 1991-05-29, under 510(k) number K911026.

Who is the listed applicant for STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE 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 STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION?

The FDA product code for STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE 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'UNIONK911020LIGAMENTOPLASTIC STAPLE OF L'UNIONK911031THE TRAMOND PIN

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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